Serious Incidents - Cochlear Aqua+ Manual Del Usuario

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
• your National Competent Authority http://ec�europa�eu/
growth/sectors/medical-devices/contacts_en
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