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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 138 08 14 000
Date submitted:
8/28/2014
Manufacturer:
Draeger Medical Systems Inc
Device Type:
Babytherm 8004/8010 and Babytherm 8000WB
Description:
infant warmers and open infant care units for newborns
Medical Device Identifier:
Babytherm 8000WB, Babytherm 8004 and Babytherm 8010
Reason of Field Safety Corrective Action:
The manufacturer became aware of an incident in which a side panel on a Babytherm 8010 did not fully slide to the bottom in the corner guides and was not completely locked.
Remedy Action:
- When reviewing the locking mechanism in a number of hospitals it was possible to fully close the side panels by pushing down on them slightly. However, it cannot be guaranteed that the panel will lock into position under its own weight. In this respect, users should pay attention to the information provided in the Instructions for Use: "Check that the side panels lock securely into position and that they remain securely locked"
- If the locking mechanism is not functioning, please contact your Drager Service representative.
Athorized Representative/Importer/Distributor:
Draeger Arabia Co. Ltd.
Report Source:
NCMDR
Source Ref. Number:
3EA7226A9C20D
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Draeger.pdf
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Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.