Medical Device Temperature Issue

Issue associated with the device producing unintended temperatures (for issues related to environmental/ambient temperatures refer to code C63307). (Food and Drug Administration)

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Medical Device Structural Problem

Issue associated with the basic physical construction or physical make up of the device.

Medical Device Stops Intermittently

Issue associated with any deviation from device document specification relating to the irregular rate at which the device stops.

Medical Device Shelf Life Exceeded

Issue associated with the using a device after the marked or known shelf life.

Medical Device Service Failure

Issue associated with the lack of periodic preventive maintenance or performance assurance checks.

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…

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…