Medical Device Sensing Issue

Issue associated with device features that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) that do not transmit a resulting signal for interpretation or measurement. (Food and Drug Administration)

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Medical Device Safety

A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range from small…

Medical Device Retraction Problem

Issue associated with drawing back the device and/or device component to an intended location.

Medical Device Reset Issue

Issue associated with setting a variable, register, or other storage location back to a prescribed state.

Medical Device Protective Measure Issue

Issue associated with any deviations from device documented performance specifications relating to the implemented and inherited design features specific to devices used…

Medical Device Problem Codes FDA CDRH

Terminology used for defining mode of medical device failure or malfunction in individual case reports for voluntary and mandatory reporting of adverse…

Medical Device Pressure Issue

Issue associated with the application of a force either internal or external to the device that compromises the flow of fluid or…