Medical device manufacturer, Philips Healthcare, has issued a field safety notice concerning HeartStart MRx Monitor/Defibrillator [Model no.: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6; Serial numbers within the range US00100100 to US00565942]

According to the manufacturer, 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. If the problem occurs, there may be a failure to deliver shock therapy to a patient in need of defibrillation or cardioversion therapy.

The manufacturer will provide software upgrade to fix the problem. However, prior to performing the software upgrade, the manufacturer recommends customer to follow step 1.

• Step 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.

• Step 2: Treat your patient per existing protocols. If possible, Philips recommends that a backup defibrillator be made available.

According to the manufacturer, the affected products were distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 19 April 2013