Reporting of serious incidents
Any serious incident related to the use of this device, should be
reported to both the manufacturer and the health authority/competent
authority where the device is installed.
To report to the manufacturer:
•
Either contact your local service representative.
•
Or report to: [email protected].
Please provide the following information:
•
The catalogue number or the model designation of the device as
stated on its identification plate affixed on the device
•
The System ID/serial number/lot number of the device
•
Date of incident
•
Description of incident, including any patient or user impact/
injury
•
Your contact information (facility, address, contact name, title,
and telephone number)
7 Alarms and troubleshooting
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