IMDRF Code Lookup Tool
IMDRF Code Lookup Tool - Free, Searchable, All 7 Annexes
Search 181 IMDRF adverse event codes by code number or keyword. Browse by annex. Includes FDA MAUDE mapping and related codes. Built by Smarteeva.
smarteevaIMDRF Code Lookup
IMDRF Code Lookup Tool
Search and browse IMDRF adverse event terminology codes across all 7 annexes. Covers Device Problems, Patient Problems, Component Types, Cause Investigation, Health Effects, Investigation Types, and Investigation Findings. Free and always up to date.
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181 codes found
All Codes(181)Annex A: Device Problem(57)Annex B: Patient Problem(32)Annex C: Component Type(21)Annex D: Cause Investigation(19)Annex E: Health Effect(12)Annex F: Investigation Type(20)Annex G: Investigation Findings(20)
All Codes
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A0101
Absorption problem
Device absorbed bodily fluids or substances when it should not have, or absorbed them at an unexpected rate.
Annex A: Device ProblemMaterial IntegrityFDA MAUDE
CodeA0101
TermAbsorption problem
AnnexAnnex A — Device Problem
CategoryMaterial Integrity
Parent GroupMaterial/Chemical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice absorbed bodily fluids or substances when it should not have, or absorbed them at an unexpected rate.
Related Codes
A0102 Biocompatibility problemA0204 CorrosionA0206 DegradationA0209 Erosion
A0102
Biocompatibility problem
Device material caused an adverse biological response in tissue or the body, including cytotoxicity, sensitization, or irritation.
Annex A: Device ProblemMaterial IntegrityFDA MAUDE
CodeA0102
TermBiocompatibility problem
AnnexAnnex A — Device Problem
CategoryMaterial Integrity
Parent GroupMaterial/Chemical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice material caused an adverse biological response in tissue or the body, including cytotoxicity, sensitization, or irritation.
Related Codes
A0101 Absorption problemA0204 CorrosionA0206 DegradationA0209 Erosion
A0201
Break
Device fractured, broke, or separated into pieces during use or prior to use.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0201
TermBreak
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice fractured, broke, or separated into pieces during use or prior to use.
Related Codes
A0202 CrackA0203 CollapseA0205 DeformationA0207 Detachment of device or device componentA0208 Device dislocation
A0202
Crack
A visible crack or fissure appeared on the device surface or structure without complete separation.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0202
TermCrack
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionA visible crack or fissure appeared on the device surface or structure without complete separation.
Related Codes
A0201 BreakA0203 CollapseA0205 DeformationA0207 Detachment of device or device componentA0208 Device dislocation
A0203
Collapse
Device structure collapsed, buckled, or lost its intended shape under normal use conditions.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0203
TermCollapse
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice structure collapsed, buckled, or lost its intended shape under normal use conditions.
Related Codes
A0201 BreakA0202 CrackA0205 DeformationA0207 Detachment of device or device componentA0208 Device dislocation
A0204
Corrosion
Device material degraded due to chemical or electrochemical reaction with the surrounding environment.
Annex A: Device ProblemMaterial IntegrityFDA MAUDE
CodeA0204
TermCorrosion
AnnexAnnex A — Device Problem
CategoryMaterial Integrity
Parent GroupMaterial/Chemical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice material degraded due to chemical or electrochemical reaction with the surrounding environment.
Related Codes
A0101 Absorption problemA0102 Biocompatibility problemA0206 DegradationA0209 Erosion
A0205
Deformation
Device changed shape permanently beyond acceptable limits, including bending, warping, or distortion.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0205
TermDeformation
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice changed shape permanently beyond acceptable limits, including bending, warping, or distortion.
Related Codes
A0201 BreakA0202 CrackA0203 CollapseA0207 Detachment of device or device componentA0208 Device dislocation
A0206
Degradation
Device material deteriorated over time through physical, chemical, or biological processes.
Annex A: Device ProblemMaterial IntegrityFDA MAUDE
CodeA0206
TermDegradation
AnnexAnnex A — Device Problem
CategoryMaterial Integrity
Parent GroupMaterial/Chemical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice material deteriorated over time through physical, chemical, or biological processes.
Related Codes
A0101 Absorption problemA0102 Biocompatibility problemA0204 CorrosionA0209 Erosion
A0207
Detachment of device or device component
A component or part of the device separated from the main body when it should have remained attached.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0207
TermDetachment of device or device component
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionA component or part of the device separated from the main body when it should have remained attached.
Related Codes
A0201 BreakA0202 CrackA0203 CollapseA0205 DeformationA0208 Device dislocation
A0208
Device dislocation
Device moved from its intended position or location during use.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0208
TermDevice dislocation
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice moved from its intended position or location during use.
Related Codes
A0201 BreakA0202 CrackA0203 CollapseA0205 DeformationA0207 Detachment of device or device component
A0209
Erosion
Device surface wore away due to friction, chemical action, or fluid flow.
Annex A: Device ProblemMaterial IntegrityFDA MAUDE
CodeA0209
TermErosion
AnnexAnnex A — Device Problem
CategoryMaterial Integrity
Parent GroupMaterial/Chemical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice surface wore away due to friction, chemical action, or fluid flow.
Related Codes
A0101 Absorption problemA0102 Biocompatibility problemA0204 CorrosionA0206 Degradation
A0210
Fatigue
Device material failed after repeated stress cycles below its ultimate strength, resulting in crack propagation.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0210
TermFatigue
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice material failed after repeated stress cycles below its ultimate strength, resulting in crack propagation.
Related Codes
A0201 BreakA0202 CrackA0203 CollapseA0205 DeformationA0207 Detachment of device or device component
A0211
Fracture
Complete or partial break in the device structure through the material cross-section.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0211
TermFracture
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionComplete or partial break in the device structure through the material cross-section.
Related Codes
A0201 BreakA0202 CrackA0203 CollapseA0205 DeformationA0207 Detachment of device or device component
A0212
Fragmentation
Device broke into multiple small pieces or fragments.
Annex A: Device ProblemMechanicalFDA MAUDE
CodeA0212
TermFragmentation
AnnexAnnex A — Device Problem
CategoryMechanical
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice broke into multiple small pieces or fragments.
Related Codes
A0201 BreakA0202 CrackA0203 CollapseA0205 DeformationA0207 Detachment of device or device component
A0301
Blockage
Device lumen, channel, or passage was obstructed, preventing intended flow of fluids, gases, or materials.
Annex A: Device ProblemFlow/DeliveryFDA MAUDE
CodeA0301
TermBlockage
AnnexAnnex A — Device Problem
CategoryFlow/Delivery
Parent GroupFluid/Gas
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice lumen, channel, or passage was obstructed, preventing intended flow of fluids, gases, or materials.
Related Codes
A0303 LeakA0304 Occlusion
A0302
Connection problem
Device failed to properly connect, couple, or mate with another device or component.
Annex A: Device ProblemConnectionFDA MAUDE
CodeA0302
TermConnection problem
AnnexAnnex A — Device Problem
CategoryConnection
Parent GroupMechanical/Physical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice failed to properly connect, couple, or mate with another device or component.
A0303
Leak
Fluid, gas, or other substance escaped from the device through an unintended path.
Annex A: Device ProblemFlow/DeliveryFDA MAUDE
CodeA0303
TermLeak
AnnexAnnex A — Device Problem
CategoryFlow/Delivery
Parent GroupFluid/Gas
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionFluid, gas, or other substance escaped from the device through an unintended path.
Related Codes
A0301 BlockageA0304 Occlusion
A0304
Occlusion
Internal passage of the device became partially or completely blocked.
Annex A: Device ProblemFlow/DeliveryFDA MAUDE
CodeA0304
TermOcclusion
AnnexAnnex A — Device Problem
CategoryFlow/Delivery
Parent GroupFluid/Gas
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInternal passage of the device became partially or completely blocked.
Related Codes
A0301 BlockageA0303 Leak
A0401
Arcing
Unintended electrical discharge between two conductive surfaces within or on the device.
Annex A: Device ProblemElectricalFDA MAUDE
CodeA0401
TermArcing
AnnexAnnex A — Device Problem
CategoryElectrical
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionUnintended electrical discharge between two conductive surfaces within or on the device.
Related Codes
A0402 Battery problemA0403 Circuit board problemA0404 Electromagnetic interferenceA0405 High impedanceA0406 Open circuit
A0402
Battery problem
Device battery failed to charge, hold charge, or discharge properly, or exhibited swelling, leaking, or overheating.
Annex A: Device ProblemElectricalFDA MAUDE
CodeA0402
TermBattery problem
AnnexAnnex A — Device Problem
CategoryElectrical
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice battery failed to charge, hold charge, or discharge properly, or exhibited swelling, leaking, or overheating.
Related Codes
A0401 ArcingA0403 Circuit board problemA0404 Electromagnetic interferenceA0405 High impedanceA0406 Open circuit
A0403
Circuit board problem
Printed circuit board or electronic assembly malfunctioned due to component failure, solder defect, or design issue.
Annex A: Device ProblemElectricalFDA MAUDE
CodeA0403
TermCircuit board problem
AnnexAnnex A — Device Problem
CategoryElectrical
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPrinted circuit board or electronic assembly malfunctioned due to component failure, solder defect, or design issue.
Related Codes
A0401 ArcingA0402 Battery problemA0404 Electromagnetic interferenceA0405 High impedanceA0406 Open circuit
A0404
Electromagnetic interference
Device performance was affected by external electromagnetic fields, or device emitted interference affecting other equipment.
Annex A: Device ProblemElectricalFDA MAUDE
CodeA0404
TermElectromagnetic interference
AnnexAnnex A — Device Problem
CategoryElectrical
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice performance was affected by external electromagnetic fields, or device emitted interference affecting other equipment.
Related Codes
A0401 ArcingA0402 Battery problemA0403 Circuit board problemA0405 High impedanceA0406 Open circuit
A0405
High impedance
Electrical resistance in the device circuit was higher than expected, affecting signal quality or power delivery.
Annex A: Device ProblemElectricalFDA MAUDE
CodeA0405
TermHigh impedance
AnnexAnnex A — Device Problem
CategoryElectrical
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionElectrical resistance in the device circuit was higher than expected, affecting signal quality or power delivery.
Related Codes
A0401 ArcingA0402 Battery problemA0403 Circuit board problemA0404 Electromagnetic interferenceA0406 Open circuit
A0406
Open circuit
Electrical circuit in the device was interrupted, preventing current flow.
Annex A: Device ProblemElectricalFDA MAUDE
CodeA0406
TermOpen circuit
AnnexAnnex A — Device Problem
CategoryElectrical
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionElectrical circuit in the device was interrupted, preventing current flow.
Related Codes
A0401 ArcingA0402 Battery problemA0403 Circuit board problemA0404 Electromagnetic interferenceA0405 High impedance
A0407
Short circuit
Unintended electrical connection between two points in the device circuit, potentially causing overcurrent or damage.
Annex A: Device ProblemElectricalFDA MAUDE
CodeA0407
TermShort circuit
AnnexAnnex A — Device Problem
CategoryElectrical
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionUnintended electrical connection between two points in the device circuit, potentially causing overcurrent or damage.
Related Codes
A0401 ArcingA0402 Battery problemA0403 Circuit board problemA0404 Electromagnetic interferenceA0405 High impedance
A0408
Power supply problem
Device power supply failed to deliver correct voltage, current, or waveform.
Annex A: Device ProblemElectricalFDA MAUDE
CodeA0408
TermPower supply problem
AnnexAnnex A — Device Problem
CategoryElectrical
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice power supply failed to deliver correct voltage, current, or waveform.
Related Codes
A0401 ArcingA0402 Battery problemA0403 Circuit board problemA0404 Electromagnetic interferenceA0405 High impedance
A0501
Software bug
Error in device software code that caused incorrect behavior, output, or system failure.
Annex A: Device ProblemSoftwareFDA MAUDE
CodeA0501
TermSoftware bug
AnnexAnnex A — Device Problem
CategorySoftware
Parent GroupSoftware/IT
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionError in device software code that caused incorrect behavior, output, or system failure.
Related Codes
A0502 Software configuration errorA0503 Software crashA0504 Software upgrade problemA0505 Network/communication problemA0506 Cybersecurity vulnerability
A0502
Software configuration error
Device software was incorrectly configured, causing unintended behavior or incorrect parameter settings.
Annex A: Device ProblemSoftwareFDA MAUDE
CodeA0502
TermSoftware configuration error
AnnexAnnex A — Device Problem
CategorySoftware
Parent GroupSoftware/IT
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice software was incorrectly configured, causing unintended behavior or incorrect parameter settings.
Related Codes
A0501 Software bugA0503 Software crashA0504 Software upgrade problemA0505 Network/communication problemA0506 Cybersecurity vulnerability
A0503
Software crash
Device software stopped responding or terminated unexpectedly during operation.
Annex A: Device ProblemSoftwareFDA MAUDE
CodeA0503
TermSoftware crash
AnnexAnnex A — Device Problem
CategorySoftware
Parent GroupSoftware/IT
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice software stopped responding or terminated unexpectedly during operation.
Related Codes
A0501 Software bugA0502 Software configuration errorA0504 Software upgrade problemA0505 Network/communication problemA0506 Cybersecurity vulnerability
A0504
Software upgrade problem
Device software update or upgrade caused new defects, compatibility issues, or loss of functionality.
Annex A: Device ProblemSoftwareFDA MAUDE
CodeA0504
TermSoftware upgrade problem
AnnexAnnex A — Device Problem
CategorySoftware
Parent GroupSoftware/IT
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice software update or upgrade caused new defects, compatibility issues, or loss of functionality.
Related Codes
A0501 Software bugA0502 Software configuration errorA0503 Software crashA0505 Network/communication problemA0506 Cybersecurity vulnerability
A0505
Network/communication problem
Device failed to communicate properly with other devices, networks, or information systems.
Annex A: Device ProblemSoftwareFDA MAUDE
CodeA0505
TermNetwork/communication problem
AnnexAnnex A — Device Problem
CategorySoftware
Parent GroupSoftware/IT
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice failed to communicate properly with other devices, networks, or information systems.
Related Codes
A0501 Software bugA0502 Software configuration errorA0503 Software crashA0504 Software upgrade problemA0506 Cybersecurity vulnerability
A0506
Cybersecurity vulnerability
Device software contained a security weakness that could be exploited to compromise device function or patient data.
Annex A: Device ProblemSoftwareFDA MAUDE
CodeA0506
TermCybersecurity vulnerability
AnnexAnnex A — Device Problem
CategorySoftware
Parent GroupSoftware/IT
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice software contained a security weakness that could be exploited to compromise device function or patient data.
Related Codes
A0501 Software bugA0502 Software configuration errorA0503 Software crashA0504 Software upgrade problemA0505 Network/communication problem
A0507
Data loss
Device lost stored data including patient information, settings, or operational logs.
Annex A: Device ProblemSoftwareFDA MAUDE
CodeA0507
TermData loss
AnnexAnnex A — Device Problem
CategorySoftware
Parent GroupSoftware/IT
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice lost stored data including patient information, settings, or operational logs.
Related Codes
A0501 Software bugA0502 Software configuration errorA0503 Software crashA0504 Software upgrade problemA0505 Network/communication problem
A0508
Display/user interface problem
Device display showed incorrect information, failed to display, or user interface responded incorrectly.
Annex A: Device ProblemSoftwareFDA MAUDE
CodeA0508
TermDisplay/user interface problem
AnnexAnnex A — Device Problem
CategorySoftware
Parent GroupSoftware/IT
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice display showed incorrect information, failed to display, or user interface responded incorrectly.
Related Codes
A0501 Software bugA0502 Software configuration errorA0503 Software crashA0504 Software upgrade problemA0505 Network/communication problem
A0601
Failure to alarm
Device alarm system failed to activate when the alarm condition was met.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0601
TermFailure to alarm
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice alarm system failed to activate when the alarm condition was met.
Related Codes
A0602 False alarmA0603 Inaccurate measurementA0604 Failure to operateA0605 Intermittent operationA0606 Overheating
A0602
False alarm
Device alarm activated when no true alarm condition existed.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0602
TermFalse alarm
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice alarm activated when no true alarm condition existed.
Related Codes
A0601 Failure to alarmA0603 Inaccurate measurementA0604 Failure to operateA0605 Intermittent operationA0606 Overheating
A0603
Inaccurate measurement
Device measurement or reading was outside acceptable accuracy limits.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0603
TermInaccurate measurement
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice measurement or reading was outside acceptable accuracy limits.
Related Codes
A0601 Failure to alarmA0602 False alarmA0604 Failure to operateA0605 Intermittent operationA0606 Overheating
A0604
Failure to operate
Device did not function at all when activated or when function was required.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0604
TermFailure to operate
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice did not function at all when activated or when function was required.
Related Codes
A0601 Failure to alarmA0602 False alarmA0603 Inaccurate measurementA0605 Intermittent operationA0606 Overheating
A0605
Intermittent operation
Device operated inconsistently, working at some times and failing at others without predictable pattern.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0605
TermIntermittent operation
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice operated inconsistently, working at some times and failing at others without predictable pattern.
Related Codes
A0601 Failure to alarmA0602 False alarmA0603 Inaccurate measurementA0604 Failure to operateA0606 Overheating
A0606
Overheating
Device temperature exceeded safe operating limits during normal or foreseeable use.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0606
TermOverheating
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice temperature exceeded safe operating limits during normal or foreseeable use.
Related Codes
A0601 Failure to alarmA0602 False alarmA0603 Inaccurate measurementA0604 Failure to operateA0605 Intermittent operation
A0607
Noise problem
Device produced excessive, unexpected, or abnormal sound during operation.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0607
TermNoise problem
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice produced excessive, unexpected, or abnormal sound during operation.
Related Codes
A0601 Failure to alarmA0602 False alarmA0603 Inaccurate measurementA0604 Failure to operateA0605 Intermittent operation
A0608
Premature discharge
Device released its therapeutic or diagnostic output before the intended time.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0608
TermPremature discharge
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice released its therapeutic or diagnostic output before the intended time.
Related Codes
A0601 Failure to alarmA0602 False alarmA0603 Inaccurate measurementA0604 Failure to operateA0605 Intermittent operation
A0609
Shelf life/expiration problem
Device failed or degraded before its stated expiration date or shelf life.
Annex A: Device ProblemOutputFDA MAUDE
CodeA0609
TermShelf life/expiration problem
AnnexAnnex A — Device Problem
CategoryOutput
Parent GroupPerformance
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice failed or degraded before its stated expiration date or shelf life.
Related Codes
A0601 Failure to alarmA0602 False alarmA0603 Inaccurate measurementA0604 Failure to operateA0605 Intermittent operation
A2003
Fluid handling - dispense
Device failed to dispense fluids at the correct rate, volume, or pressure. Includes over-delivery and under-delivery.
Annex A: Device ProblemFluid HandlingFDA MAUDE
CodeA2003
TermFluid handling - dispense
AnnexAnnex A — Device Problem
CategoryFluid Handling
Parent GroupFluid/Gas
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice failed to dispense fluids at the correct rate, volume, or pressure. Includes over-delivery and under-delivery.
Related Codes
A2008 Fluid handling - aspiration
A2008
Fluid handling - aspiration
Device failed to aspirate fluids correctly. Includes failure to draw fluid, incorrect aspiration volume, or unintended aspiration.
Annex A: Device ProblemFluid HandlingFDA MAUDE
CodeA2008
TermFluid handling - aspiration
AnnexAnnex A — Device Problem
CategoryFluid Handling
Parent GroupFluid/Gas
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice failed to aspirate fluids correctly. Includes failure to draw fluid, incorrect aspiration volume, or unintended aspiration.
Related Codes
A2003 Fluid handling - dispense
A0701
Labeling problem
Device label was incorrect, missing, illegible, or did not conform to requirements.
Annex A: Device ProblemLabelingFDA MAUDE
CodeA0701
TermLabeling problem
AnnexAnnex A — Device Problem
CategoryLabeling
Parent GroupLabeling/Packaging
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice label was incorrect, missing, illegible, or did not conform to requirements.
Related Codes
A0703 Instructions for use problem
A0702
Packaging problem
Device packaging was damaged, inadequate, or did not maintain sterility or device integrity.
Annex A: Device ProblemPackagingFDA MAUDE
CodeA0702
TermPackaging problem
AnnexAnnex A — Device Problem
CategoryPackaging
Parent GroupLabeling/Packaging
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice packaging was damaged, inadequate, or did not maintain sterility or device integrity.
A0703
Instructions for use problem
Device instructions were incorrect, incomplete, unclear, or missing critical safety information.
Annex A: Device ProblemLabelingFDA MAUDE
CodeA0703
TermInstructions for use problem
AnnexAnnex A — Device Problem
CategoryLabeling
Parent GroupLabeling/Packaging
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice instructions were incorrect, incomplete, unclear, or missing critical safety information.
Related Codes
A0701 Labeling problem
A1306
Sensor - level detection
Device sensor failed to correctly detect or measure fluid, gas, or material levels.
Annex A: Device ProblemSensorFDA MAUDE
CodeA1306
TermSensor - level detection
AnnexAnnex A — Device Problem
CategorySensor
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice sensor failed to correctly detect or measure fluid, gas, or material levels.
Related Codes
A1301 Sensor - pressureA1302 Sensor - temperatureA1303 Sensor - flowA1304 Sensor - opticalA1305 Sensor - position
A1301
Sensor - pressure
Device pressure sensor provided inaccurate readings or failed to detect pressure changes.
Annex A: Device ProblemSensorFDA MAUDE
CodeA1301
TermSensor - pressure
AnnexAnnex A — Device Problem
CategorySensor
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice pressure sensor provided inaccurate readings or failed to detect pressure changes.
Related Codes
A1306 Sensor - level detectionA1302 Sensor - temperatureA1303 Sensor - flowA1304 Sensor - opticalA1305 Sensor - position
A1302
Sensor - temperature
Device temperature sensor provided inaccurate readings or failed to detect temperature changes.
Annex A: Device ProblemSensorFDA MAUDE
CodeA1302
TermSensor - temperature
AnnexAnnex A — Device Problem
CategorySensor
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice temperature sensor provided inaccurate readings or failed to detect temperature changes.
Related Codes
A1306 Sensor - level detectionA1301 Sensor - pressureA1303 Sensor - flowA1304 Sensor - opticalA1305 Sensor - position
A1303
Sensor - flow
Device flow sensor failed to accurately measure or detect fluid or gas flow rates.
Annex A: Device ProblemSensorFDA MAUDE
CodeA1303
TermSensor - flow
AnnexAnnex A — Device Problem
CategorySensor
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice flow sensor failed to accurately measure or detect fluid or gas flow rates.
Related Codes
A1306 Sensor - level detectionA1301 Sensor - pressureA1302 Sensor - temperatureA1304 Sensor - opticalA1305 Sensor - position
A1304
Sensor - optical
Device optical sensor failed to detect light, images, or optical signals correctly.
Annex A: Device ProblemSensorFDA MAUDE
CodeA1304
TermSensor - optical
AnnexAnnex A — Device Problem
CategorySensor
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice optical sensor failed to detect light, images, or optical signals correctly.
Related Codes
A1306 Sensor - level detectionA1301 Sensor - pressureA1302 Sensor - temperatureA1303 Sensor - flowA1305 Sensor - position
A1305
Sensor - position
Device position or motion sensor failed to accurately detect device or component position.
Annex A: Device ProblemSensorFDA MAUDE
CodeA1305
TermSensor - position
AnnexAnnex A — Device Problem
CategorySensor
Parent GroupElectrical/Electronic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice position or motion sensor failed to accurately detect device or component position.
Related Codes
A1306 Sensor - level detectionA1301 Sensor - pressureA1302 Sensor - temperatureA1303 Sensor - flowA1304 Sensor - optical
A0801
Sterility problem
Device was not sterile when it should have been, or sterile barrier was compromised.
Annex A: Device ProblemSterilityFDA MAUDE
CodeA0801
TermSterility problem
AnnexAnnex A — Device Problem
CategorySterility
Parent GroupSterility/Contamination
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice was not sterile when it should have been, or sterile barrier was compromised.
Related Codes
A0802 ContaminationA0803 Reprocessing problem
A0802
Contamination
Device was contaminated with foreign material, particulates, or biological agents.
Annex A: Device ProblemSterilityFDA MAUDE
CodeA0802
TermContamination
AnnexAnnex A — Device Problem
CategorySterility
Parent GroupSterility/Contamination
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice was contaminated with foreign material, particulates, or biological agents.
Related Codes
A0801 Sterility problemA0803 Reprocessing problem
A0803
Reprocessing problem
Device could not be properly cleaned, disinfected, or sterilized for reuse.
Annex A: Device ProblemSterilityFDA MAUDE
CodeA0803
TermReprocessing problem
AnnexAnnex A — Device Problem
CategorySterility
Parent GroupSterility/Contamination
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice could not be properly cleaned, disinfected, or sterilized for reuse.
Related Codes
A0801 Sterility problemA0802 Contamination
B0101
Abrasion
Patient skin was scraped or worn away by friction with the device surface.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0101
TermAbrasion
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient skin was scraped or worn away by friction with the device surface.
Related Codes
B0103 BurnB0104 BruisingB0108 Compression of tissue/organB0112 EdemaB0119 Laceration
B0102
Allergic reaction
Patient developed an immune-mediated hypersensitivity response to the device or its materials.
Annex B: Patient ProblemImmunologicalFDA MAUDE
CodeB0102
TermAllergic reaction
AnnexAnnex B — Patient Problem
CategoryImmunological
Parent GroupBiological Response
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed an immune-mediated hypersensitivity response to the device or its materials.
Related Codes
B0118 Inflammation
B0103
Burn
Patient tissue was damaged by thermal, chemical, electrical, or radiation energy from the device.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0103
TermBurn
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient tissue was damaged by thermal, chemical, electrical, or radiation energy from the device.
Related Codes
B0101 AbrasionB0104 BruisingB0108 Compression of tissue/organB0112 EdemaB0119 Laceration
B0104
Bruising
Patient developed bruising or contusion at the device interaction site.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0104
TermBruising
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed bruising or contusion at the device interaction site.
Related Codes
B0101 AbrasionB0103 BurnB0108 Compression of tissue/organB0112 EdemaB0119 Laceration
B0105
Cardiac arrest
Patient experienced cessation of cardiac function associated with device use.
Annex B: Patient ProblemCardiovascularFDA MAUDE
CodeB0105
TermCardiac arrest
AnnexAnnex B — Patient Problem
CategoryCardiovascular
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced cessation of cardiac function associated with device use.
Related Codes
B0106 Cardiac arrhythmiaB0113 EmbolismB0115 Haemorrhage
B0106
Cardiac arrhythmia
Patient developed an abnormal heart rhythm associated with device use.
Annex B: Patient ProblemCardiovascularFDA MAUDE
CodeB0106
TermCardiac arrhythmia
AnnexAnnex B — Patient Problem
CategoryCardiovascular
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed an abnormal heart rhythm associated with device use.
Related Codes
B0105 Cardiac arrestB0113 EmbolismB0115 Haemorrhage
B0107
Choking
Patient experienced airway obstruction related to the device.
Annex B: Patient ProblemRespiratoryFDA MAUDE
CodeB0107
TermChoking
AnnexAnnex B — Patient Problem
CategoryRespiratory
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced airway obstruction related to the device.
Related Codes
B0110 Difficulty breathing
B0108
Compression of tissue/organ
Device applied excessive pressure on adjacent tissue or organs.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0108
TermCompression of tissue/organ
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice applied excessive pressure on adjacent tissue or organs.
Related Codes
B0101 AbrasionB0103 BurnB0104 BruisingB0112 EdemaB0119 Laceration
B0109
Death
Patient death was associated with device use or malfunction.
Annex B: Patient ProblemDeathFDA MAUDE
CodeB0109
TermDeath
AnnexAnnex B — Patient Problem
CategoryDeath
Parent GroupFatal Outcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient death was associated with device use or malfunction.
B0110
Difficulty breathing
Patient experienced respiratory distress or dyspnea associated with device use.
Annex B: Patient ProblemRespiratoryFDA MAUDE
CodeB0110
TermDifficulty breathing
AnnexAnnex B — Patient Problem
CategoryRespiratory
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced respiratory distress or dyspnea associated with device use.
Related Codes
B0107 Choking
B0111
Dizziness
Patient experienced lightheadedness, vertigo, or unsteadiness associated with device use.
Annex B: Patient ProblemNeurologicalFDA MAUDE
CodeB0111
TermDizziness
AnnexAnnex B — Patient Problem
CategoryNeurological
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced lightheadedness, vertigo, or unsteadiness associated with device use.
Related Codes
B0116 HeadacheB0122 Nerve damageB0128 SeizureB0130 Stroke
B0112
Edema
Patient developed swelling due to fluid accumulation at or near the device site.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0112
TermEdema
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed swelling due to fluid accumulation at or near the device site.
Related Codes
B0101 AbrasionB0103 BurnB0104 BruisingB0108 Compression of tissue/organB0119 Laceration
B0113
Embolism
A blood clot, air bubble, or foreign body traveled through the bloodstream, associated with device use.
Annex B: Patient ProblemCardiovascularFDA MAUDE
CodeB0113
TermEmbolism
AnnexAnnex B — Patient Problem
CategoryCardiovascular
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionA blood clot, air bubble, or foreign body traveled through the bloodstream, associated with device use.
Related Codes
B0105 Cardiac arrestB0106 Cardiac arrhythmiaB0115 Haemorrhage
B0114
Fever
Patient developed elevated body temperature associated with device use.
Annex B: Patient ProblemSystemicFDA MAUDE
CodeB0114
TermFever
AnnexAnnex B — Patient Problem
CategorySystemic
Parent GroupBiological Response
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed elevated body temperature associated with device use.
B0115
Haemorrhage
Patient experienced bleeding associated with device use or device site.
Annex B: Patient ProblemCardiovascularFDA MAUDE
CodeB0115
TermHaemorrhage
AnnexAnnex B — Patient Problem
CategoryCardiovascular
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced bleeding associated with device use or device site.
Related Codes
B0105 Cardiac arrestB0106 Cardiac arrhythmiaB0113 Embolism
B0116
Headache
Patient developed headache associated with device use.
Annex B: Patient ProblemNeurologicalFDA MAUDE
CodeB0116
TermHeadache
AnnexAnnex B — Patient Problem
CategoryNeurological
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed headache associated with device use.
Related Codes
B0111 DizzinessB0122 Nerve damageB0128 SeizureB0130 Stroke
B0117
Infection
Patient developed a localized or systemic infection associated with the device.
Annex B: Patient ProblemInfectionFDA MAUDE
CodeB0117
TermInfection
AnnexAnnex B — Patient Problem
CategoryInfection
Parent GroupBiological Response
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed a localized or systemic infection associated with the device.
Related Codes
B0129 Sepsis
B0118
Inflammation
Patient tissue showed signs of inflammation (redness, swelling, heat, pain) at the device site.
Annex B: Patient ProblemImmunologicalFDA MAUDE
CodeB0118
TermInflammation
AnnexAnnex B — Patient Problem
CategoryImmunological
Parent GroupBiological Response
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient tissue showed signs of inflammation (redness, swelling, heat, pain) at the device site.
Related Codes
B0102 Allergic reaction
B0119
Laceration
Patient tissue was cut or torn by the device.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0119
TermLaceration
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient tissue was cut or torn by the device.
Related Codes
B0101 AbrasionB0103 BurnB0104 BruisingB0108 Compression of tissue/organB0112 Edema
B0120
Nausea
Patient experienced nausea associated with device use.
Annex B: Patient ProblemGastrointestinalFDA MAUDE
CodeB0120
TermNausea
AnnexAnnex B — Patient Problem
CategoryGastrointestinal
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced nausea associated with device use.
B0121
Necrosis
Patient tissue died at or near the device site.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0121
TermNecrosis
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient tissue died at or near the device site.
Related Codes
B0101 AbrasionB0103 BurnB0104 BruisingB0108 Compression of tissue/organB0112 Edema
B0122
Nerve damage
Patient experienced peripheral or central nerve injury associated with device use.
Annex B: Patient ProblemNeurologicalFDA MAUDE
CodeB0122
TermNerve damage
AnnexAnnex B — Patient Problem
CategoryNeurological
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced peripheral or central nerve injury associated with device use.
Related Codes
B0111 DizzinessB0116 HeadacheB0128 SeizureB0130 Stroke
B0123
No patient problem
No adverse health effect was identified in the patient.
Annex B: Patient ProblemNoneFDA MAUDE
CodeB0123
TermNo patient problem
AnnexAnnex B — Patient Problem
CategoryNone
Parent GroupNo Effect
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionNo adverse health effect was identified in the patient.
B0124
Pain
Patient reported pain at the device site or systemically associated with device use.
Annex B: Patient ProblemPainFDA MAUDE
CodeB0124
TermPain
AnnexAnnex B — Patient Problem
CategoryPain
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient reported pain at the device site or systemically associated with device use.
B0125
Perforation
Device created an unintended hole or puncture in tissue or organ.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0125
TermPerforation
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice created an unintended hole or puncture in tissue or organ.
Related Codes
B0101 AbrasionB0103 BurnB0104 BruisingB0108 Compression of tissue/organB0112 Edema
B0126
Rash
Patient developed a skin rash at or near the device site.
Annex B: Patient ProblemDermatologicalFDA MAUDE
CodeB0126
TermRash
AnnexAnnex B — Patient Problem
CategoryDermatological
Parent GroupBiological Response
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed a skin rash at or near the device site.
B0127
Scarring
Patient developed scar tissue at the device site.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0127
TermScarring
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed scar tissue at the device site.
Related Codes
B0101 AbrasionB0103 BurnB0104 BruisingB0108 Compression of tissue/organB0112 Edema
B0128
Seizure
Patient experienced seizure activity associated with device use.
Annex B: Patient ProblemNeurologicalFDA MAUDE
CodeB0128
TermSeizure
AnnexAnnex B — Patient Problem
CategoryNeurological
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced seizure activity associated with device use.
Related Codes
B0111 DizzinessB0116 HeadacheB0122 Nerve damageB0130 Stroke
B0129
Sepsis
Patient developed systemic infection and inflammatory response associated with device use.
Annex B: Patient ProblemInfectionFDA MAUDE
CodeB0129
TermSepsis
AnnexAnnex B — Patient Problem
CategoryInfection
Parent GroupBiological Response
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient developed systemic infection and inflammatory response associated with device use.
Related Codes
B0117 Infection
B0130
Stroke
Patient experienced cerebrovascular event associated with device use.
Annex B: Patient ProblemNeurologicalFDA MAUDE
CodeB0130
TermStroke
AnnexAnnex B — Patient Problem
CategoryNeurological
Parent GroupOrgan System
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced cerebrovascular event associated with device use.
Related Codes
B0111 DizzinessB0116 HeadacheB0122 Nerve damageB0128 Seizure
B0131
Tissue damage
Patient tissue sustained injury or damage from the device beyond what was intended.
Annex B: Patient ProblemInjuryFDA MAUDE
CodeB0131
TermTissue damage
AnnexAnnex B — Patient Problem
CategoryInjury
Parent GroupPhysical Injury
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient tissue sustained injury or damage from the device beyond what was intended.
Related Codes
B0101 AbrasionB0103 BurnB0104 BruisingB0108 Compression of tissue/organB0112 Edema
B0132
Toxic reaction
Patient experienced adverse effects due to toxic substances released by or associated with the device.
Annex B: Patient ProblemToxicologicalFDA MAUDE
CodeB0132
TermToxic reaction
AnnexAnnex B — Patient Problem
CategoryToxicological
Parent GroupBiological Response
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced adverse effects due to toxic substances released by or associated with the device.
C0101
Actuator
Component that converts energy into mechanical motion within the device.
Annex C: Component TypeMechanical
CodeC0101
TermActuator
AnnexAnnex C — Component Type
CategoryMechanical
Parent GroupElectromechanical
FDA MAUDENot directly mapped
DescriptionComponent that converts energy into mechanical motion within the device.
Related Codes
C0115 Motor/pump
C0102
Adapter/connector
Component used to join or connect device parts, accessories, or external systems.
Annex C: Component TypeConnection
CodeC0102
TermAdapter/connector
AnnexAnnex C — Component Type
CategoryConnection
Parent GroupInterconnect
FDA MAUDENot directly mapped
DescriptionComponent used to join or connect device parts, accessories, or external systems.
C0103
Battery
Energy storage component providing electrical power to the device.
Annex C: Component TypePowerFDA MAUDE
CodeC0103
TermBattery
AnnexAnnex C — Component Type
CategoryPower
Parent GroupElectrical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionEnergy storage component providing electrical power to the device.
C0104
Cable/wire
Conductive pathway for electrical signals or power within or between devices.
Annex C: Component TypeElectrical
CodeC0104
TermCable/wire
AnnexAnnex C — Component Type
CategoryElectrical
Parent GroupElectrical
FDA MAUDENot directly mapped
DescriptionConductive pathway for electrical signals or power within or between devices.
C0105
Catheter
Tubular component inserted into the body for fluid delivery, drainage, or access.
Annex C: Component TypeFluid PathFDA MAUDE
CodeC0105
TermCatheter
AnnexAnnex C — Component Type
CategoryFluid Path
Parent GroupPatient Interface
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionTubular component inserted into the body for fluid delivery, drainage, or access.
Related Codes
C0109 FilterC0112 Infusion setC0120 TubingC0121 Valve
C0106
Circuit board/PCB
Printed circuit board containing electronic components and conductive traces.
Annex C: Component TypeElectronicsFDA MAUDE
CodeC0106
TermCircuit board/PCB
AnnexAnnex C — Component Type
CategoryElectronics
Parent GroupElectrical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPrinted circuit board containing electronic components and conductive traces.
Related Codes
C0114 Memory/storage
C0107
Display/screen
Visual output component showing information, images, or data to the user.
Annex C: Component TypeInterface
CodeC0107
TermDisplay/screen
AnnexAnnex C — Component Type
CategoryInterface
Parent GroupUser Interface
FDA MAUDENot directly mapped
DescriptionVisual output component showing information, images, or data to the user.
C0108
Electrode
Conductive component that interfaces with biological tissue for sensing or stimulation.
Annex C: Component TypePatient InterfaceFDA MAUDE
CodeC0108
TermElectrode
AnnexAnnex C — Component Type
CategoryPatient Interface
Parent GroupPatient Interface
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionConductive component that interfaces with biological tissue for sensing or stimulation.
Related Codes
C0116 Needle
C0109
Filter
Component that removes particulates, organisms, or substances from fluid or gas streams.
Annex C: Component TypeFluid Path
CodeC0109
TermFilter
AnnexAnnex C — Component Type
CategoryFluid Path
Parent GroupFiltration
FDA MAUDENot directly mapped
DescriptionComponent that removes particulates, organisms, or substances from fluid or gas streams.
Related Codes
C0105 CatheterC0112 Infusion setC0120 TubingC0121 Valve
C0110
Housing/enclosure
Outer shell or casing that protects internal device components.
Annex C: Component TypeStructural
CodeC0110
TermHousing/enclosure
AnnexAnnex C — Component Type
CategoryStructural
Parent GroupMechanical
FDA MAUDENot directly mapped
DescriptionOuter shell or casing that protects internal device components.
C0111
Implant component
Component designed to be placed permanently or temporarily within the body.
Annex C: Component TypeImplantFDA MAUDE
CodeC0111
TermImplant component
AnnexAnnex C — Component Type
CategoryImplant
Parent GroupPatient Interface
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionComponent designed to be placed permanently or temporarily within the body.
C0112
Infusion set
Tubing and needle assembly for delivering fluids or medications to the patient.
Annex C: Component TypeFluid PathFDA MAUDE
CodeC0112
TermInfusion set
AnnexAnnex C — Component Type
CategoryFluid Path
Parent GroupPatient Interface
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionTubing and needle assembly for delivering fluids or medications to the patient.
Related Codes
C0105 CatheterC0109 FilterC0120 TubingC0121 Valve
C0113
Lens
Optical component used to focus, filter, or direct light in the device.
Annex C: Component TypeOptical
CodeC0113
TermLens
AnnexAnnex C — Component Type
CategoryOptical
Parent GroupOptical
FDA MAUDENot directly mapped
DescriptionOptical component used to focus, filter, or direct light in the device.
C0114
Memory/storage
Component that stores data, software, or device settings.
Annex C: Component TypeElectronics
CodeC0114
TermMemory/storage
AnnexAnnex C — Component Type
CategoryElectronics
Parent GroupElectrical
FDA MAUDENot directly mapped
DescriptionComponent that stores data, software, or device settings.
Related Codes
C0106 Circuit board/PCB
C0115
Motor/pump
Component that creates mechanical motion or drives fluid/gas flow.
Annex C: Component TypeMechanicalFDA MAUDE
CodeC0115
TermMotor/pump
AnnexAnnex C — Component Type
CategoryMechanical
Parent GroupElectromechanical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionComponent that creates mechanical motion or drives fluid/gas flow.
Related Codes
C0101 Actuator
C0116
Needle
Sharp pointed component for piercing tissue or accessing body cavities.
Annex C: Component TypePatient InterfaceFDA MAUDE
CodeC0116
TermNeedle
AnnexAnnex C — Component Type
CategoryPatient Interface
Parent GroupPatient Interface
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionSharp pointed component for piercing tissue or accessing body cavities.
Related Codes
C0108 Electrode
C0117
O-ring/seal/gasket
Component that provides a fluid or gas-tight seal between device parts.
Annex C: Component TypeSealing
CodeC0117
TermO-ring/seal/gasket
AnnexAnnex C — Component Type
CategorySealing
Parent GroupMechanical
FDA MAUDENot directly mapped
DescriptionComponent that provides a fluid or gas-tight seal between device parts.
C0118
Sensor/transducer
Component that detects and converts physical quantities into electrical signals.
Annex C: Component TypeSensorFDA MAUDE
CodeC0118
TermSensor/transducer
AnnexAnnex C — Component Type
CategorySensor
Parent GroupElectrical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionComponent that detects and converts physical quantities into electrical signals.
C0119
Software/firmware
Programmed instructions controlling device operation and behavior.
Annex C: Component TypeSoftwareFDA MAUDE
CodeC0119
TermSoftware/firmware
AnnexAnnex C — Component Type
CategorySoftware
Parent GroupDigital
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionProgrammed instructions controlling device operation and behavior.
C0120
Tubing
Hollow cylindrical component for fluid or gas transport within the device system.
Annex C: Component TypeFluid Path
CodeC0120
TermTubing
AnnexAnnex C — Component Type
CategoryFluid Path
Parent GroupFluid Path
FDA MAUDENot directly mapped
DescriptionHollow cylindrical component for fluid or gas transport within the device system.
Related Codes
C0105 CatheterC0109 FilterC0112 Infusion setC0121 Valve
C0121
Valve
Component that controls the direction, flow rate, or pressure of fluid or gas.
Annex C: Component TypeFluid Path
CodeC0121
TermValve
AnnexAnnex C — Component Type
CategoryFluid Path
Parent GroupMechanical
FDA MAUDENot directly mapped
DescriptionComponent that controls the direction, flow rate, or pressure of fluid or gas.
Related Codes
C0105 CatheterC0109 FilterC0112 Infusion setC0120 Tubing
D0101
Design problem
Root cause traced to a flaw in the device design, including specifications, risk analysis, or design verification.
Annex D: Cause InvestigationDesignFDA MAUDE
CodeD0101
TermDesign problem
AnnexAnnex D — Cause Investigation
CategoryDesign
Parent GroupSystematic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to a flaw in the device design, including specifications, risk analysis, or design verification.
D0102
Manufacturing problem
Root cause traced to the manufacturing process, including assembly, machining, or production controls.
Annex D: Cause InvestigationManufacturingFDA MAUDE
CodeD0102
TermManufacturing problem
AnnexAnnex D — Cause Investigation
CategoryManufacturing
Parent GroupSystematic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to the manufacturing process, including assembly, machining, or production controls.
D0103
Material problem
Root cause traced to raw materials, including composition, purity, or material properties.
Annex D: Cause InvestigationMaterialFDA MAUDE
CodeD0103
TermMaterial problem
AnnexAnnex D — Cause Investigation
CategoryMaterial
Parent GroupSystematic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to raw materials, including composition, purity, or material properties.
D0104
Software design problem
Root cause traced to errors in software requirements, architecture, or coding.
Annex D: Cause InvestigationSoftwareFDA MAUDE
CodeD0104
TermSoftware design problem
AnnexAnnex D — Cause Investigation
CategorySoftware
Parent GroupDesign
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to errors in software requirements, architecture, or coding.
D0201
Use error
Root cause traced to incorrect use of the device by the user, including misuse and foreseeable misuse.
Annex D: Cause InvestigationUseFDA MAUDE
CodeD0201
TermUse error
AnnexAnnex D — Cause Investigation
CategoryUse
Parent GroupHuman Factors
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to incorrect use of the device by the user, including misuse and foreseeable misuse.
D0202
Inadequate training
Root cause traced to insufficient user training or competency for device operation.
Annex D: Cause InvestigationTrainingFDA MAUDE
CodeD0202
TermInadequate training
AnnexAnnex D — Cause Investigation
CategoryTraining
Parent GroupHuman Factors
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to insufficient user training or competency for device operation.
D0203
Inadequate instructions for use
Root cause traced to instructions that were unclear, incomplete, or incorrect.
Annex D: Cause InvestigationLabelingFDA MAUDE
CodeD0203
TermInadequate instructions for use
AnnexAnnex D — Cause Investigation
CategoryLabeling
Parent GroupHuman Factors
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to instructions that were unclear, incomplete, or incorrect.
D0301
Transport/storage problem
Root cause traced to improper handling, transport, or storage conditions.
Annex D: Cause InvestigationSupply ChainFDA MAUDE
CodeD0301
TermTransport/storage problem
AnnexAnnex D — Cause Investigation
CategorySupply Chain
Parent GroupEnvironmental
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to improper handling, transport, or storage conditions.
Related Codes
D0501 Supplier/third-party component issue
D0302
Environmental conditions
Root cause traced to environmental factors such as temperature, humidity, electromagnetic interference, or altitude.
Annex D: Cause InvestigationEnvironmentFDA MAUDE
CodeD0302
TermEnvironmental conditions
AnnexAnnex D — Cause Investigation
CategoryEnvironment
Parent GroupEnvironmental
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to environmental factors such as temperature, humidity, electromagnetic interference, or altitude.
D0303
Cleaning/disinfection/sterilization problem
Root cause traced to inadequate or improper reprocessing of a reusable device.
Annex D: Cause InvestigationReprocessingFDA MAUDE
CodeD0303
TermCleaning/disinfection/sterilization problem
AnnexAnnex D — Cause Investigation
CategoryReprocessing
Parent GroupEnvironmental
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to inadequate or improper reprocessing of a reusable device.
D0401
Wear and tear
Root cause traced to normal degradation of the device over its intended service life.
Annex D: Cause InvestigationLifecycleFDA MAUDE
CodeD0401
TermWear and tear
AnnexAnnex D — Cause Investigation
CategoryLifecycle
Parent GroupUse-Related
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to normal degradation of the device over its intended service life.
Related Codes
D0402 Use beyond intended service life
D0402
Use beyond intended service life
Device was used beyond its recommended lifespan, number of uses, or expiration date.
Annex D: Cause InvestigationLifecycleFDA MAUDE
CodeD0402
TermUse beyond intended service life
AnnexAnnex D — Cause Investigation
CategoryLifecycle
Parent GroupUse-Related
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice was used beyond its recommended lifespan, number of uses, or expiration date.
Related Codes
D0401 Wear and tear
D0403
Intentional misuse
Device was deliberately used in a manner contrary to its intended purpose.
Annex D: Cause InvestigationMisuse
CodeD0403
TermIntentional misuse
AnnexAnnex D — Cause Investigation
CategoryMisuse
Parent GroupUse-Related
FDA MAUDENot directly mapped
DescriptionDevice was deliberately used in a manner contrary to its intended purpose.
D0501
Supplier/third-party component issue
Root cause traced to a component or material supplied by a third party.
Annex D: Cause InvestigationSupply ChainFDA MAUDE
CodeD0501
TermSupplier/third-party component issue
AnnexAnnex D — Cause Investigation
CategorySupply Chain
Parent GroupSystematic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to a component or material supplied by a third party.
Related Codes
D0301 Transport/storage problem
D0502
Change control issue
Root cause traced to inadequate management of design, manufacturing, or process changes.
Annex D: Cause InvestigationQuality SystemFDA MAUDE
CodeD0502
TermChange control issue
AnnexAnnex D — Cause Investigation
CategoryQuality System
Parent GroupSystematic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to inadequate management of design, manufacturing, or process changes.
Related Codes
D0503 Quality management system issue
D0503
Quality management system issue
Root cause traced to systemic failures in the manufacturer's quality management system.
Annex D: Cause InvestigationQuality SystemFDA MAUDE
CodeD0503
TermQuality management system issue
AnnexAnnex D — Cause Investigation
CategoryQuality System
Parent GroupSystematic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionRoot cause traced to systemic failures in the manufacturer's quality management system.
Related Codes
D0502 Change control issue
D0601
No cause identified
Investigation was unable to determine the root cause of the event.
Annex D: Cause InvestigationUnknownFDA MAUDE
CodeD0601
TermNo cause identified
AnnexAnnex D — Cause Investigation
CategoryUnknown
Parent GroupUndetermined
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation was unable to determine the root cause of the event.
Related Codes
D0602 Insufficient information
D0602
Insufficient information
Available information was insufficient to complete a root cause investigation.
Annex D: Cause InvestigationUnknownFDA MAUDE
CodeD0602
TermInsufficient information
AnnexAnnex D — Cause Investigation
CategoryUnknown
Parent GroupUndetermined
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionAvailable information was insufficient to complete a root cause investigation.
Related Codes
D0601 No cause identified
D0801
Failure to run
Device failed to initiate or sustain its intended function or operating cycle.
Annex D: Cause InvestigationPerformanceFDA MAUDE
CodeD0801
TermFailure to run
AnnexAnnex D — Cause Investigation
CategoryPerformance
Parent GroupSystematic
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice failed to initiate or sustain its intended function or operating cycle.
E0101
No consequences or impact to patient
The device event occurred but did not result in any health consequence to the patient.
Annex E: Health EffectNo EffectFDA MAUDE
CodeE0101
TermNo consequences or impact to patient
AnnexAnnex E — Health Effect
CategoryNo Effect
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionThe device event occurred but did not result in any health consequence to the patient.
E0102
Minor injury or impairment
Patient experienced a minor, temporary, and reversible health effect.
Annex E: Health EffectMinorFDA MAUDE
CodeE0102
TermMinor injury or impairment
AnnexAnnex E — Health Effect
CategoryMinor
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced a minor, temporary, and reversible health effect.
E0103
Serious injury
Patient experienced a significant injury requiring medical intervention, hospitalization, or resulting in permanent impairment.
Annex E: Health EffectSeriousFDA MAUDE
CodeE0103
TermSerious injury
AnnexAnnex E — Health Effect
CategorySerious
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient experienced a significant injury requiring medical intervention, hospitalization, or resulting in permanent impairment.
Related Codes
E0106 Required intervention to prevent permanent impairment
E0104
Life-threatening
Patient's life was at immediate risk as a result of the device event.
Annex E: Health EffectCriticalFDA MAUDE
CodeE0104
TermLife-threatening
AnnexAnnex E — Health Effect
CategoryCritical
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient's life was at immediate risk as a result of the device event.
E0105
Death
Patient death occurred as a result of or associated with the device event.
Annex E: Health EffectFatalFDA MAUDE
CodeE0105
TermDeath
AnnexAnnex E — Health Effect
CategoryFatal
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient death occurred as a result of or associated with the device event.
Related Codes
E0205 Fetal/neonatal death
E0106
Required intervention to prevent permanent impairment
Medical or surgical intervention was necessary to prevent lasting damage to the patient.
Annex E: Health EffectSeriousFDA MAUDE
CodeE0106
TermRequired intervention to prevent permanent impairment
AnnexAnnex E — Health Effect
CategorySerious
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionMedical or surgical intervention was necessary to prevent lasting damage to the patient.
Related Codes
E0103 Serious injury
E0201
Hospitalization (initial or prolonged)
Patient required initial hospitalization or extension of existing hospitalization due to the device event.
Annex E: Health EffectHospitalizationFDA MAUDE
CodeE0201
TermHospitalization (initial or prolonged)
AnnexAnnex E — Health Effect
CategoryHospitalization
Parent GroupHealthcare Impact
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient required initial hospitalization or extension of existing hospitalization due to the device event.
E0202
Additional medical/surgical procedure
Patient required an unplanned medical or surgical procedure as a result of the device event.
Annex E: Health EffectInterventionFDA MAUDE
CodeE0202
TermAdditional medical/surgical procedure
AnnexAnnex E — Health Effect
CategoryIntervention
Parent GroupHealthcare Impact
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient required an unplanned medical or surgical procedure as a result of the device event.
Related Codes
E0203 Device explant/removal required
E0203
Device explant/removal required
Device had to be surgically removed or replaced due to the event.
Annex E: Health EffectInterventionFDA MAUDE
CodeE0203
TermDevice explant/removal required
AnnexAnnex E — Health Effect
CategoryIntervention
Parent GroupHealthcare Impact
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice had to be surgically removed or replaced due to the event.
Related Codes
E0202 Additional medical/surgical procedure
E0204
Disability or permanent damage
Patient sustained a permanent functional impairment or disability.
Annex E: Health EffectPermanentFDA MAUDE
CodeE0204
TermDisability or permanent damage
AnnexAnnex E — Health Effect
CategoryPermanent
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient sustained a permanent functional impairment or disability.
E0205
Fetal/neonatal death
Death of a fetus or neonate associated with device use during pregnancy or delivery.
Annex E: Health EffectFatalFDA MAUDE
CodeE0205
TermFetal/neonatal death
AnnexAnnex E — Health Effect
CategoryFatal
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDeath of a fetus or neonate associated with device use during pregnancy or delivery.
Related Codes
E0105 Death
E0206
Congenital anomaly/birth defect
A birth defect or congenital anomaly was associated with device use during pregnancy.
Annex E: Health EffectCongenitalFDA MAUDE
CodeE0206
TermCongenital anomaly/birth defect
AnnexAnnex E — Health Effect
CategoryCongenital
Parent GroupOutcome
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionA birth defect or congenital anomaly was associated with device use during pregnancy.
F0101
Visual inspection
External and internal examination of the device to identify visible damage, wear, contamination, or anomalies.
Annex F: Investigation TypePhysicalFDA MAUDE
CodeF0101
TermVisual inspection
AnnexAnnex F — Investigation Type
CategoryPhysical
Parent GroupNon-Destructive
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionExternal and internal examination of the device to identify visible damage, wear, contamination, or anomalies.
Related Codes
F0114 Returned device analysis
F0102
Chemical analysis
Testing to determine the chemical composition, contamination, or degradation of device materials.
Annex F: Investigation TypeAnalyticalFDA MAUDE
CodeF0102
TermChemical analysis
AnnexAnnex F — Investigation Type
CategoryAnalytical
Parent GroupLaboratory
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionTesting to determine the chemical composition, contamination, or degradation of device materials.
Related Codes
F0109 Failure mode analysisF0110 Root cause analysisF0116 Materials characterizationF0118 Comparative analysis
F0103
Electrical testing
Measurement of electrical parameters including impedance, continuity, insulation resistance, and leakage current.
Annex F: Investigation TypeElectricalFDA MAUDE
CodeF0103
TermElectrical testing
AnnexAnnex F — Investigation Type
CategoryElectrical
Parent GroupNon-Destructive
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionMeasurement of electrical parameters including impedance, continuity, insulation resistance, and leakage current.
F0104
Functional testing
Verification that the device performs its intended functions within specified operating parameters.
Annex F: Investigation TypeFunctionalFDA MAUDE
CodeF0104
TermFunctional testing
AnnexAnnex F — Investigation Type
CategoryFunctional
Parent GroupNon-Destructive
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionVerification that the device performs its intended functions within specified operating parameters.
Related Codes
F0113 Simulated use testing
F0105
Mechanical testing
Evaluation of structural integrity, strength, fatigue resistance, and mechanical performance of the device or component.
Annex F: Investigation TypeMechanicalFDA MAUDE
CodeF0105
TermMechanical testing
AnnexAnnex F — Investigation Type
CategoryMechanical
Parent GroupLaboratory
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionEvaluation of structural integrity, strength, fatigue resistance, and mechanical performance of the device or component.
F0106
Microbiological testing
Testing for microbial contamination including bioburden, sterility, endotoxin, and biofilm assessment.
Annex F: Investigation TypeBiologicalFDA MAUDE
CodeF0106
TermMicrobiological testing
AnnexAnnex F — Investigation Type
CategoryBiological
Parent GroupLaboratory
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionTesting for microbial contamination including bioburden, sterility, endotoxin, and biofilm assessment.
Related Codes
F0107 Biocompatibility testing
F0107
Biocompatibility testing
Assessment of biological response to device materials including cytotoxicity, sensitization, and irritation testing.
Annex F: Investigation TypeBiologicalFDA MAUDE
CodeF0107
TermBiocompatibility testing
AnnexAnnex F — Investigation Type
CategoryBiological
Parent GroupLaboratory
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionAssessment of biological response to device materials including cytotoxicity, sensitization, and irritation testing.
Related Codes
F0106 Microbiological testing
F0108
Software analysis
Review and testing of device software including code review, log analysis, fault injection, and verification of algorithms.
Annex F: Investigation TypeSoftwareFDA MAUDE
CodeF0108
TermSoftware analysis
AnnexAnnex F — Investigation Type
CategorySoftware
Parent GroupAnalytical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionReview and testing of device software including code review, log analysis, fault injection, and verification of algorithms.
F0109
Failure mode analysis
Systematic investigation to identify the mechanism, location, and progression of device failure.
Annex F: Investigation TypeAnalyticalFDA MAUDE
CodeF0109
TermFailure mode analysis
AnnexAnnex F — Investigation Type
CategoryAnalytical
Parent GroupRoot Cause
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionSystematic investigation to identify the mechanism, location, and progression of device failure.
Related Codes
F0102 Chemical analysisF0110 Root cause analysisF0116 Materials characterizationF0118 Comparative analysis
F0110
Root cause analysis
Structured investigation to identify the fundamental cause or causes that led to the adverse event.
Annex F: Investigation TypeAnalyticalFDA MAUDE
CodeF0110
TermRoot cause analysis
AnnexAnnex F — Investigation Type
CategoryAnalytical
Parent GroupRoot Cause
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionStructured investigation to identify the fundamental cause or causes that led to the adverse event.
Related Codes
F0102 Chemical analysisF0109 Failure mode analysisF0116 Materials characterizationF0118 Comparative analysis
F0111
Complaint trending / statistical analysis
Analysis of complaint patterns, frequencies, and trends over time to identify systemic issues or emerging signals.
Annex F: Investigation TypeStatisticalFDA MAUDE
CodeF0111
TermComplaint trending / statistical analysis
AnnexAnnex F — Investigation Type
CategoryStatistical
Parent GroupData Analysis
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionAnalysis of complaint patterns, frequencies, and trends over time to identify systemic issues or emerging signals.
F0112
Risk analysis review
Review or update of the device risk management file, hazard analysis, and risk-benefit assessment in response to the event.
Annex F: Investigation TypeRiskFDA MAUDE
CodeF0112
TermRisk analysis review
AnnexAnnex F — Investigation Type
CategoryRisk
Parent GroupAnalytical
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionReview or update of the device risk management file, hazard analysis, and risk-benefit assessment in response to the event.
F0113
Simulated use testing
Reproduction of reported conditions in a controlled environment to replicate the failure or adverse event.
Annex F: Investigation TypeFunctionalFDA MAUDE
CodeF0113
TermSimulated use testing
AnnexAnnex F — Investigation Type
CategoryFunctional
Parent GroupLaboratory
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionReproduction of reported conditions in a controlled environment to replicate the failure or adverse event.
Related Codes
F0104 Functional testing
F0114
Returned device analysis
Physical and functional examination of the actual device returned from the field following the reported event.
Annex F: Investigation TypePhysicalFDA MAUDE
CodeF0114
TermReturned device analysis
AnnexAnnex F — Investigation Type
CategoryPhysical
Parent GroupNon-Destructive
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPhysical and functional examination of the actual device returned from the field following the reported event.
Related Codes
F0101 Visual inspection
F0115
Imaging / radiographic analysis
Use of X-ray, CT, MRI, or other imaging methods to examine internal device structures without disassembly.
Annex F: Investigation TypeImaging
CodeF0115
TermImaging / radiographic analysis
AnnexAnnex F — Investigation Type
CategoryImaging
Parent GroupNon-Destructive
FDA MAUDENot directly mapped
DescriptionUse of X-ray, CT, MRI, or other imaging methods to examine internal device structures without disassembly.
F0116
Materials characterization
Detailed analysis of material properties including metallurgy, polymer characterization, surface analysis, and fractography.
Annex F: Investigation TypeAnalytical
CodeF0116
TermMaterials characterization
AnnexAnnex F — Investigation Type
CategoryAnalytical
Parent GroupLaboratory
FDA MAUDENot directly mapped
DescriptionDetailed analysis of material properties including metallurgy, polymer characterization, surface analysis, and fractography.
Related Codes
F0102 Chemical analysisF0109 Failure mode analysisF0110 Root cause analysisF0118 Comparative analysis
F0117
Environmental testing
Evaluation of device performance under stress conditions including temperature, humidity, vibration, and altitude.
Annex F: Investigation TypeEnvironmental
CodeF0117
TermEnvironmental testing
AnnexAnnex F — Investigation Type
CategoryEnvironmental
Parent GroupLaboratory
FDA MAUDENot directly mapped
DescriptionEvaluation of device performance under stress conditions including temperature, humidity, vibration, and altitude.
F0118
Comparative analysis
Side-by-side comparison of the reported device with a reference or control device of the same lot or model.
Annex F: Investigation TypeAnalyticalFDA MAUDE
CodeF0118
TermComparative analysis
AnnexAnnex F — Investigation Type
CategoryAnalytical
Parent GroupNon-Destructive
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionSide-by-side comparison of the reported device with a reference or control device of the same lot or model.
Related Codes
F0102 Chemical analysisF0109 Failure mode analysisF0110 Root cause analysisF0116 Materials characterization
F0119
Manufacturing record review
Review of device history record, batch records, and manufacturing documentation for deviations or non-conformances.
Annex F: Investigation TypeDocumentationFDA MAUDE
CodeF0119
TermManufacturing record review
AnnexAnnex F — Investigation Type
CategoryDocumentation
Parent GroupData Analysis
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionReview of device history record, batch records, and manufacturing documentation for deviations or non-conformances.
F0120
No investigation conducted
No formal investigation was conducted. May be due to non-return of device, insufficient information, or risk-based decision.
Annex F: Investigation TypeNoneFDA MAUDE
CodeF0120
TermNo investigation conducted
AnnexAnnex F — Investigation Type
CategoryNone
Parent GroupNot Investigated
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionNo formal investigation was conducted. May be due to non-return of device, insufficient information, or risk-based decision.
G0101
Device deficiency confirmed
Investigation confirmed the device had a deficiency that caused or contributed to the reported adverse event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0101
TermDevice deficiency confirmed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupDevice-Related
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation confirmed the device had a deficiency that caused or contributed to the reported adverse event.
Related Codes
G0105 Use error confirmedG0106 Patient condition contributedG0107 External factors contributedG0108 Manufacturing deviation confirmedG0109 Design deficiency confirmed
G0102
No device deficiency found
Investigation found no deficiency or malfunction in the device. Device performed within its intended specifications.
Annex G: Investigation FindingsNot ConfirmedFDA MAUDE
CodeG0102
TermNo device deficiency found
AnnexAnnex G — Investigation Findings
CategoryNot Confirmed
Parent GroupDevice-Related
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation found no deficiency or malfunction in the device. Device performed within its intended specifications.
Related Codes
G0104 Device performed as intended
G0103
Inconclusive
Investigation could not conclusively determine whether a device deficiency existed or contributed to the event.
Annex G: Investigation FindingsUndeterminedFDA MAUDE
CodeG0103
TermInconclusive
AnnexAnnex G — Investigation Findings
CategoryUndetermined
Parent GroupUndetermined
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation could not conclusively determine whether a device deficiency existed or contributed to the event.
G0104
Device performed as intended
Device functioned within its design specifications and intended use. Reported outcome was within expected performance.
Annex G: Investigation FindingsNot ConfirmedFDA MAUDE
CodeG0104
TermDevice performed as intended
AnnexAnnex G — Investigation Findings
CategoryNot Confirmed
Parent GroupDevice-Related
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionDevice functioned within its design specifications and intended use. Reported outcome was within expected performance.
Related Codes
G0102 No device deficiency found
G0105
Use error confirmed
Investigation confirmed the event resulted from incorrect use of the device, including foreseeable misuse.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0105
TermUse error confirmed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupUser-Related
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation confirmed the event resulted from incorrect use of the device, including foreseeable misuse.
Related Codes
G0101 Device deficiency confirmedG0106 Patient condition contributedG0107 External factors contributedG0108 Manufacturing deviation confirmedG0109 Design deficiency confirmed
G0106
Patient condition contributed
Patient's pre-existing condition, anatomy, or physiological state contributed to the reported adverse event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0106
TermPatient condition contributed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupPatient-Related
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionPatient's pre-existing condition, anatomy, or physiological state contributed to the reported adverse event.
Related Codes
G0101 Device deficiency confirmedG0105 Use error confirmedG0107 External factors contributedG0108 Manufacturing deviation confirmedG0109 Design deficiency confirmed
G0107
External factors contributed
Factors outside the device and user, such as environmental conditions, other devices, or medications, contributed to the event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0107
TermExternal factors contributed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupExternal
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionFactors outside the device and user, such as environmental conditions, other devices, or medications, contributed to the event.
Related Codes
G0101 Device deficiency confirmedG0105 Use error confirmedG0106 Patient condition contributedG0108 Manufacturing deviation confirmedG0109 Design deficiency confirmed
G0108
Manufacturing deviation confirmed
Investigation identified a deviation from manufacturing specifications that caused or contributed to the event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0108
TermManufacturing deviation confirmed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupManufacturing
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation identified a deviation from manufacturing specifications that caused or contributed to the event.
Related Codes
G0101 Device deficiency confirmedG0105 Use error confirmedG0106 Patient condition contributedG0107 External factors contributedG0109 Design deficiency confirmed
G0109
Design deficiency confirmed
Investigation identified a flaw in the device design that caused or contributed to the event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0109
TermDesign deficiency confirmed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupDesign
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation identified a flaw in the device design that caused or contributed to the event.
Related Codes
G0101 Device deficiency confirmedG0105 Use error confirmedG0106 Patient condition contributedG0107 External factors contributedG0108 Manufacturing deviation confirmed
G0110
Labeling deficiency confirmed
Investigation identified that inadequate, incorrect, or missing labeling contributed to the event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0110
TermLabeling deficiency confirmed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupLabeling
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation identified that inadequate, incorrect, or missing labeling contributed to the event.
Related Codes
G0111
Packaging deficiency confirmed
Investigation identified that packaging failure or inadequacy contributed to the event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0111
TermPackaging deficiency confirmed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupPackaging
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation identified that packaging failure or inadequacy contributed to the event.
Related Codes
G0112
Material deficiency confirmed
Investigation identified that a material property, composition, or degradation issue contributed to the event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0112
TermMaterial deficiency confirmed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupMaterial
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation identified that a material property, composition, or degradation issue contributed to the event.
Related Codes
G0113
Software deficiency confirmed
Investigation identified a software error, bug, or configuration issue that caused or contributed to the event.
Annex G: Investigation FindingsConfirmedFDA MAUDE
CodeG0113
TermSoftware deficiency confirmed
AnnexAnnex G — Investigation Findings
CategoryConfirmed
Parent GroupSoftware
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation identified a software error, bug, or configuration issue that caused or contributed to the event.
Related Codes
G0114
Investigation ongoing
Investigation has not been completed. Findings are pending further analysis, testing, or information.
Annex G: Investigation FindingsPendingFDA MAUDE
CodeG0114
TermInvestigation ongoing
AnnexAnnex G — Investigation Findings
CategoryPending
Parent GroupUndetermined
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation has not been completed. Findings are pending further analysis, testing, or information.
G0115
Unable to investigate - device not returned
Investigation could not be conducted because the device was not available for examination.
Annex G: Investigation FindingsNot InvestigatedFDA MAUDE
CodeG0115
TermUnable to investigate - device not returned
AnnexAnnex G — Investigation Findings
CategoryNot Investigated
Parent GroupUndetermined
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation could not be conducted because the device was not available for examination.
G0116
Corrective action initiated
Based on investigation findings, the manufacturer initiated corrective action (CAPA, field safety corrective action, or recall).
Annex G: Investigation FindingsAction TakenFDA MAUDE
CodeG0116
TermCorrective action initiated
AnnexAnnex G — Investigation Findings
CategoryAction Taken
Parent GroupResolution
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionBased on investigation findings, the manufacturer initiated corrective action (CAPA, field safety corrective action, or recall).
Related Codes
G0117 Preventive action initiated
G0117
Preventive action initiated
Based on investigation findings, the manufacturer initiated preventive action to reduce the likelihood of recurrence.
Annex G: Investigation FindingsAction TakenFDA MAUDE
CodeG0117
TermPreventive action initiated
AnnexAnnex G — Investigation Findings
CategoryAction Taken
Parent GroupResolution
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionBased on investigation findings, the manufacturer initiated preventive action to reduce the likelihood of recurrence.
Related Codes
G0116 Corrective action initiated
G0118
No action required
Investigation concluded that no corrective or preventive action is required based on the findings.
Annex G: Investigation FindingsNo ActionFDA MAUDE
CodeG0118
TermNo action required
AnnexAnnex G — Investigation Findings
CategoryNo Action
Parent GroupResolution
FDA MAUDEYes — used in FDA adverse event reporting
DescriptionInvestigation concluded that no corrective or preventive action is required based on the findings.
G0119
Benefit-risk assessment unchanged
Investigation concluded that the overall benefit-risk profile of the device remains acceptable despite the event.
Annex G: Investigation FindingsAssessment
CodeG0119
TermBenefit-risk assessment unchanged
AnnexAnnex G — Investigation Findings
CategoryAssessment
Parent GroupResolution
FDA MAUDENot directly mapped
DescriptionInvestigation concluded that the overall benefit-risk profile of the device remains acceptable despite the event.
Related Codes
G0120 Benefit-risk assessment changed
G0120
Benefit-risk assessment changed
Investigation concluded that the event materially impacts the benefit-risk profile of the device, requiring further action.
Annex G: Investigation FindingsAssessment
CodeG0120
TermBenefit-risk assessment changed
AnnexAnnex G — Investigation Findings
CategoryAssessment
Parent GroupResolution
FDA MAUDENot directly mapped
DescriptionInvestigation concluded that the event materially impacts the benefit-risk profile of the device, requiring further action.
Related Codes
G0119 Benefit-risk assessment unchanged
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Data sourced from IMDRF Adverse Event Terminology (IMDRF/AER WG/N43FINAL:2020) and FDA MAUDE database.
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