Medical Device Optical Issue

Issue associated with any deviations from specifications relating to device operations (e.g. deployment, connection, electrical, computer software, infusion/flow, output, protective-measure, and incompatibility…

Issue associated with any deviations from expected performance while operating and using the device.

A grouping of medical devices based upon model name or number.

Issue associated with the use of the device characterized by users' incorrect assembly of device components, parts or constituents.

Issues associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc.

Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material