Incident for Medical Device (MEDDEV definition)

Any malfunction or deterioration in the characteristics and/or performance of a device, including use-error due to ergonomic features, as well as any inadequacy in the labeling or the instructions for use supplied by the manufacturer which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.