Cochlear Kanso Halo, User Manual

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18 Kanso Halo Accessory 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
www.cochlear.com/intl/contact/global-offices
• For users within the European Union, you should also report
serious incidents to your National Competent Authority,
http://ec.europa.eu/growth/sectors/medical-devices/
contacts_en
• For users outside of the European Union, if applicable, report
serious incidents to your National Competent Authority,
• For users within Australia, report serious incidents to the
Therapeutic Goods Administration https://www.tga.gov.au