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Reporting an accident or incident
If an accident or an incident associated with the sterilizers occurs, this
must be reported immediately in writing to the address below. The
report must be used to identify the cause of the accident or incident and
to what extent the occurrence was due to the unit
The unit is a product in the GETINGE range.
The unit may also be a sterilizer that is a medical engineering product
and which conforms to the EU medical devices directive, or which is
constructed in a similar way to a medical device. Under the medical
devices directive, the manufacturer must investigate the cause of
accidents/incidents that occur and report them to the authorities
concerned.
The investigation may lead to changes in new or already delivered
devices or in instructions and guidance.
The following circumstances must be reported:
1. Circumstances that caused the death of a patient, user or someone
else, or that caused serious deterioration in the health of a patient,
user or someone else.
2. Circumstances that might have caused, the death of a patient, user
or someone else, or that might have caused serious deterioration in
the health of a patient, user or someone else.
The following information is required:
The manufacturing number of the unit (on a label in the electrical
cabinet), Date/time of event, Description of event, Consequences of
event.
Contact: Name, Phone number, Address:, E-mail:
The information must be sent by letter or fax to:
GETINGE STERILIZATION AB
For the attention of: Quality Manager
Box 69
31044 GETINGE
Sweden
Fax: +46 (0)35 549 52
Use this information when reporting incidents and
accidents involving the unit.
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