Medical Device Service Failure

Issue associated with device features that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) that do not…

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

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

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

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

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