Medical Dictionary for Regulatory Activities System Organ Class

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

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

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

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

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

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