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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 123 04 12 000
Date submitted: 4/30/2012
Manufacturer:Pace Medical, Inc
Device Type:TEMPORARY EXTERNAL PACING (WITHOUT DEFIBRILLATION), MICRO-PACE
Description:TEMPORARY, EXTERNAL, MICRO-PACE
Medical Device Identifier:MICRO-PACE - 4580
Reason of Field Safety Corrective Action:It has been reported to the Company that some Users of the REF 4580 have encountered the failure of a MOSFET which can affect the output of the device. Typical failure has been seen where the output has been compromised on either the atrial or ventricular channel of the device. Devices with this potential have been identified by serial number.
Remedy Action:Return your device(s) to the Company for a complimentary upgrade. You may use the REF 4580 while scheduling your return to our facility; however it is recommended that patients are monitored while the device is in use.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:UK-2012-04-27-082
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments