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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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Reference Number:	mdprc 113 04 13 001
Date submitted:	7/11/2013

Manufacturer:	Philips Healthcare
Device Type:	Defibrillator, HeartStart MRx Monitor/Defibrillator
Description:	Monitor/Defibrillator
Medical Device Identifier:	model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Units Affected: Serial numbers within the range US00100100 to US00565942.
Reason of Field Safety Corrective Action:	The Philips HeartStart MRx Monitor/Defibrillator may fail to deliver defibrillation therapy in either Manual Defib or AED mode. If this occurs, the MRx may simultaneously display a “No Shock Delivered” message along with a “Shock Equip Malfunction” INOP and a Red X in the RFU indicator. In addition, the pads ECG waveform may display a non-physiologic flat line rhythm.
Remedy Action:	ACTION TO BE TAKEN BY CUSTOMER / USER: A software upgrade fixes this problem. To continue to use your MRx prior to receiving the software upgrade you must follow step 1. 1. If the problem occurs, disregard the MRx “No Shock Delivered”, “Shock Equip Malfunction”, INOP and the Red X. Press the lead select button to display another ECG waveform and continue to administer additional shock therapy as needed. If Step 1 does not resolve the problem follow step 2. 2. Treat your patient per existing protocols. If possible, Philips recommends that a backup defibrillator be made available. ACTIONS PLANNED BY PHILIPS: Philips is initiating a correction to affected devices. The correction will consist of a software upgrade and will be provided free of charge to all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the software upgrade ................................... Swissmedic Update Action : IF you have tried to shock your patient and simultaneously observe the following symptoms  Flat line ECG  “Device error. Service required.” message  “Shock Equip Malfunction” INOP  Red X in the RFU indicator THEN 1. Turn off device 2. Wait at least 10 seconds 3. Turn on device 4. Acknowledge the “Device error. Service required” message 5. Observe the patient’s physiological rhythm 6. Continue to administer shock therapy as needed. IMPORTANT NOTES: Upon Restart a “Device error. Service required” message will display which will clear after pressing the menu select button to acknowledge the message. Restarting the device will not clear the Red X and “Shock Equip Malfunction” INOP. Ignore these symptoms while continuing to administer shock therapy. Perform an Op-Check later to clear these symptoms.
Athorized Representative/Importer/Distributor:	Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:	NCMDR
Source Ref. Number:	DBAD1381B92D5
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Vk_20130501_13 ( Philips Healthcare ).pdf

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