MDR reportable event

The threshold is 'reasonably suggests', so a manufacturer does not need proof that the device caused the event. Malfunctions count when the device or a similar one would be likely to cause or contribute to death or serious injury if the malfunction happened again.

MDR reportable event (or reportable event) means: (1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or (2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices: (i) May have caused or contributed to a death or serious injury, or (ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

21 CFR, 803.3