5.3.03 Incidents involving medical devices

Aim and purpose

Notification of the managing director, the members of the board of directors and the clinic directors of special incidents on the premises and in the operation of the hospital. The notification must be made without delay using the reporting channels described so that the management can take appropriate countermeasures and possibly inform the public. DIN EN ISO 6.1, 10.2.1; JCI QPS.7;

Application

Users and operators of medical devices.

Description of the procedure

6 Notes and comments

Note the batch and serial numbers of accessories (e.g. ventilation tubes) and keep the accessories for future reference.

7 Applicable documents

7.1 Regulations

Medical Devices User Notification and Information Ordinance - MPAMIV

7.2 Terms

64th occurrence
A malfunction or deterioration in the characteristics or performance of a product already made available on the market, including application errors due to ergonomic features, as well as an inadequacy of the information provided by the manufacturer or an undesirable side effect;
65. serious incident An incident that has had, could have had or could have had, directly or indirectly, any of the following consequences: a) the death of a patient, user or other person, b) the temporary or permanent serious deterioration in the state of health of a patient, user or other person, c) a serious risk to public health
Medical Devices Directive EU) 2017/745 Article 2

Suspected serious incident
an occurrence which cannot be excluded as being due to an undesirable side effect of a product, a malfunction, a deterioration in the characteristics or performance of a product, including errors in use due to ergonomic features or an inadequacy in the information provided by the manufacturer, and which directly or indirectly had or could have had one of the following consequences:
1. the death of a patient, user or other person,
2. the temporary or permanent serious deterioration in the state of health of a patient, user or other person, or
3. a serious risk to public health.
MPAMIV:2021

Attachments

Reporting of incidents and SAEs involving medical devices via the DIMDI https://www.dimdi.de/static/de/mpg/ismp/meld/index.htm Here you can find the forms for notifications and the corresponding regulations