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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 005 12 14 000
Date submitted: 12/1/2014
Manufacturer:Philips Healthcare
Device Type:Philips M1783A and M5526A Sync Cables
Description:Monitor/Defibrillators
Medical Device Identifier:Product: Philips Sync Cables, models M1783A and M5526A

Units Affected: All Philips sync cables, models M1783A and M5526A, are affected.
Reason of Field Safety Corrective Action:When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power:

-On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave

-On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing*.
Remedy Action:Prior to receiving a replacement sync cable, you can continue to use affected sync cables, provided that they are only used to connect the ECG Out jack on the monitor/defibrillator to the ECG (input) port on a bedside monitor. The issues described in this letter do not impact this application of the sync cable. Affected sync cables should not be used to connect the ECG Out jack of a bedside monitor to the ECG (input) port on the monitor/defibrillator.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:C737AC12A6262
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare-4.pdf