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Any serious incident that has occurred in relation to the
CROS device, should be reported to the manufacturer
representative and the competent authority of the state of
residence. A serious incident is described as any incident
that directly or indirectly led, might have led or might lead
to any of the following:
a) the death of a patient, user or other person
b) the temporary or permanent serious deterioration of
apatient’s, user’s or other person’s state of health
c) a serious public health threat
To report an unexpected operation or event, please contact
the manufacturer representative.
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