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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 024 02 11 000
Date submitted: 2/13/2011
Manufacturer:Philips Healthcare
Device Type:HeartStart MRx monitor/defibrillators
Description:Defibrillator/Pacemakers, External
Medical Device Identifier:All HeartStart MRx monitor/defibrillators, models M3535A and M3536A with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp.
Reason of Field Safety Corrective Action:This device use modes can result in the EtCO2 and ventilation rate values displaying interchangeably under either the ventilation rate label or the EtCO2 label, Potentially Resulting in Inappropriate Treatment
Remedy Action:A Philips service engineer will contact your facility to arrange to install software version F.01.03 or R.01.00. Until your software is updated, Philips states that you may continue to use affected product.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh (01) 2119999
Report Source:NCMDR
Source Ref. Number:3234DAC063263
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: 201102PhilipsHeartStartMFRUSCustomerLetter.pdf