- An event has occurred
- The Manufacturer’s device is suspected to be a contributory cause of the incident
- The event led, or might on re-occurence, lead to one of the following outcomes: death or serious deterioration in state of health of a patient, user or other person
- Public Health Threat: 2 calendar days
- Death or Serious deterioration in health occurred: 10 calendar days
- All other incidents 30 calendar days