Medical Device Reset Issue

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…

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

Issue associated with the movement of the device and/or device components to an intended location.

Issue associated with the materials used to construct the cover or outer wrapping of the device.

Issue associated with any deviation from device documented performance specifications relating to the end result, data, or test results provided by the…