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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 067 08 11 000
Date submitted: 8/22/2011
Manufacturer:GS Elektromedizinische Geraete G Stemple GmbH
Device Type:Corpuls Defibrillator
Description:Defibrillator/Pacemakers, External
Medical Device Identifier:Corpuls3 Defibrillator. Model: 04000
Reason of Field Safety Corrective Action:An error in the processor supply voltage can sporadically lead to non-reproducible bugs. The errors range from false-positive alarms to the temporary breakdown of measurement- and therapy functions.
Remedy Action:This security information will be sent to all affected users until 31.08.2011. Maintenance for each device will be promptly arranged. A new processor board with Revision BA0000000F or higher is going to be installed, so you will shortly have a fully operable unit. For the duration of this procedure a replacement device will be supplied.
Athorized Representative/Importer/Distributor:Beta Scientific Instruments Co. Ltd, Riyadh (01) 2060433
Report Source:NCMDR
Source Ref. Number:CEFA7035F4361
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: TB_008_GB.pdf