a. The use of medical devices can lead to undesirable events or side effects in the same way that medicinal products can have side effects.
b. The law defines an event involving a medical device as an incident. This can be impaired functioning, for example, or a change in characteristics, incorrect labelling or instructions for use that have resulted or could have resulted in death or serious impairment of the health of patients, users or third-parties.
c. In this context it is not important whether this incident is somebody's "fault".
i. Revision of a prosthetic hip joint, for example as a result of pain, loosening or a broken shaft
ii. Failure of the brake on a rollator in spite of regular maintenance
iii. Detachment of a tube from an infusion set in the absence of evident force having been exerted on the site of the tear
1 Official wording as used in 93/42/EEC concerning medical devices, 98/79/EC on in vitro diagnostic medical devices, 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices: Incident used as translation of “schwerwiegendes Vorkommnis”, Event used as translation of “Vorkommnis”