Manufacturers, importers, and device user facilities have reporting obligations when a device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that could. Reports feed the publicly searchable MAUDE database.

Where This Gets Misread

Attributing harm to software is much harder than attributing it to hardware. If a triage device failed to flag a hemorrhage that was later read normally by a radiologist and the patient deteriorated, establishing the device's contribution is difficult and reporting is inconsistent. Under-reporting in this category is expected, not exceptional.