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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 004 09 17 000
Date submitted: 9/3/2017
Manufacturer:TRUMPF Medizin Systeme GmbH.
Device Type:Universal Arm Support
Description:Arm Support
Medical Device Identifier:Product Name Model Number up to serial number Universal Arm Support 450 1697630 103106579 Universal Arm Support 450 T 1697635 103011318 Universal Arm Support 600 1697639 102631713 Universal Arm Support 600 T 1697651 102968819 Universal Arm Support 450 U 1697660 102956866 Universal Arm Support 450 U T 1697662 102945650
Reason of Field Safety Corrective Action:During 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. investigation indicates this is typically seen prior to initial use or during set-up, but the clamping could also deteriorate over time. The product has not been involved with any reported injuries, and there are no known safety risks related to it. As a reminder, the Universal Arm Support is used to position and restrain a patient’s arm securely during surgery, as well as the induction and recovery phases
Remedy Action:Check that all mechanical functions and parts are undamaged and in good working order prior to each use in accordance with the Instructions For Use (Instruction Manual). In cases where the device is defective, damaged, leaking oil or will not hold its set position, stop the use of the device and contact Trumpf Medical: TM_FSCA_MOD@hill-rom.com.
Athorized Representative/Importer/Distributor:Medical regulations gate
Report Source:NCMDR
Source Ref. Number:2DED9ED7A032F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Trumpf Medical.pdf