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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 049 04 16 000
Date submitted: 4/12/2016
Manufacturer:Trumpf Medical Systems, Inc.
Device Type:Universal Arm Support
Description:Arm Support
Medical Device Identifier:Product Name: Universal Arm Support 450 Model Number: 1697630 up to serial number: 102441510

Product Name: Universal Arm Support 450 T Model Number: 1697635 up to serial number: 102472407

Product Name: Universal Arm Support 600 Model Number: 1697639 up to serial number: 102406761

Product Name: Universal Arm Support 600 T Model Number: 1697651 up to serial number: 102412823

Product Name: Universal Arm Support 450 U Model Number: 1697660 up to serial number: 102426024

Product Name: Universal Arm Support 450 U T Model Number: 1697662 up to serial number: 102452250
Reason of Field Safety Corrective Action:The Universal Arm Support enables precise positioning of the patient’s arm during surgical procedures. During our continuous monitoring and analysis of Trumpf Medical products installed in the field customers have reported that the Universal Arm Support may be unable to hold its set position and support the arm of the patient. The feedback describes the issue occurring while attempting to secure the position of the device. With this preventive field action Trumpf Medical proactively wants to ensure the safe intended use of the Universal Arm Support. The product has not been involved with any reported injuries.
Remedy Action:1. Check the affected devices before every use for the correct functionality of the hydraulic clamping. This has to be done in the following way:

- Attach the Universal Arm Support to the side rail of the operating table top. - Position the pad according to Picture 1 and fix the hand wheel. - Push down on the pad with approximately 10 kg and check if the hand wheel is opening by itself. If the hand wheel does not open by itself and the Universal Arm Support will hold its position you are able to continue to use the device. In other cases stop the use of the device and contact your Trumpf Medical representative immediately.

2. Trumpf Medical will provide a modification of the Universal Arm Support. The parts will become available after June 2016 and you will be contacted by your authorized Trumpf Medical service partner to arrange service.

3. Please complete the Confirmation of Receipt (Attachment 1) and include a contact person to arrange the repair.
Athorized Representative/Importer/Distributor:Medical regulations gate
Report Source:NCMDR
Source Ref. Number:5C3210B0D3221
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Trumpf Medical Systems.pdf