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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 118 02 14 002
Date submitted: 2/13/2017
Manufacturer:Draeger Medical Systems Inc
Device Type:Optional Power Supply Unit PS500, used in connection with multiple Draeger devices
Description:Optional Power Supply Unit PS500 used in connection with
Evita Infinity V500, Babylog VN500 or Evita V300
Medical Device Identifier:.
Reason of Field Safety Corrective Action:Battery capacity will not last as long as expected, failure of the “Battery low” and “Battery depleted” alarm
Remedy Action:You will be contacted by your Dräger representative to organize a battery exchange as an interim solution.

Until this exchange of the battery, Dräger recommends:
1. Use an affected device for patient transport only if absolutely necessary.
2. Do not rely on the battery charge status indicator.
3. Always supervise the patient and the ventilator during transport. Ensure to have a breathing bag available for manual ventilation as recommended in the instruction for use.
4. If power fail alarm occurs during transport, provide manual ventilation and immediately connect the ventilator to wall power to resume ventilation.

After the battery exchange, Dräger recommends to: 1. Minimise battery usage
2. Avoid very short usage and charging of the PS500 (1 – 20 minutes)
3. Avoid patient transport lasting longer than 1 hour
4. Assure charging of the batteries for at least 24 hours

The exchange of the batteries is only a temporary solution. The manufacturer is working to provide a permanent solution as quickly as possible. As soon as this permanent solution is available, you will be contacted by a Dräger service representative again to arrange the implementation of the permanent solution.

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FDA update Action:
The new battery that Draeger exchanged with the previous corrective action was tested and qualified. However, Draeger learned that the supplier had a production process issue with these batteries that may lead to shorter battery life times. As a consequence, Dräger has decided to replace all batteries for the PS500 again.
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TGA update action:

Dräger has now developed device modifications to rectify the issue.
The device modifications include the following:
- Installation of a new software 2.50 with improved battery charge management - Improved charge management for external batteries
- Option of performing a battery check to determine the battery's current runtime - Option of displaying the remaining battery capacity in minutes
- Installation of an additional internal backup battery
- Replacement of the power supply unit to support both the external battery and an additional internal battery
- Replacement of the existing external batteries.
The installation of a backup battery will ensure that the internal battery will continue to supply power should the external battery fail.
Athorized Representative/Importer/Distributor:Draeger Arabia Co. Ltd., (011) 4623000
Report Source:http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00176-1
Source Ref. Number:0D8E39B884210, RC-2017-RN-00176-1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments