SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 015 09 18 000
Date submitted:	9/9/2018

Manufacturer:	Philips Burton
Device Type:	Philips Efficia DFM100 Defibrillator/ Monitor
Description:	Defibrillator/ Monitor
Medical Device Identifier:	Product: Philips Efficia DFM100 Defibrillator/ Monitor with model numbers 866199. Units Affected: World Wide devices with certain configurations only: AED Only, AED+SpO2, AED+CO2 or AED+SpO2 +NBP.
Reason of Field Safety Corrective Action:	Philips has identified the possibility that, on rare occasion, the Philips Efficia DFM100 Defibrillator/ Monitor (P/N 866199) –, when powered-on in AED mode, may stop operating and reboot.
Remedy Action:	-Upgrade device software to the latest version S-453564462801-REL Rev. 2.00.14 or greater. -Philips will provide a new software version for the affected devices to prevent the behavior description., Philips requests you contact us if your device fails to function as intended.
Athorized Representative/Importer/Distributor:	Philips Healthcare Saudi Arabia Ltd.
Report Source:	NCMDR
Source Ref. Number:	F2237619DF283
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Philips Helathcare.pdf

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