User Guide

17AQUA+ FOR KANSO® 2 USER GUIDE

Serious incidents

Whilst serious incidents in relation to medical devices are

rare, it is acknowledged that incidents may happen. As an

organisation, Cochlear recognises the potential for harm and

will respond to any reported serious incident.

What is a serious incident?

A ‘serious incident’ means any event that directly or indirectly

has caused or could have caused an unexpected or unwanted

event including any of the following:

• The death of a patient, user or other person,

• The temporary or permanent serious deterioration of a

patient’s, user’s or other person’s state of health,

• A serious public health threat.

Reporting a serious incident

There is no deﬁnitive list of events/incidents that constitute

a serious incident, however all serious incidents should be

reported to:

• your local Cochlear ofﬁce