Medical device manufacturer, Philips Healthcare, has issued a field safety notice (FSN) concerning HeartStart MRx Monitor/Defibrillator. The affected model numbers are M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC, and the affected serial numbers are within the range US00100100 - US00550668.
The ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal. Interruption of the ECG signal can cause loss of demand mode pacing, inability to perform synchronized cardioversion with paddles, and disruption of leads ECG monitoring, which could delay appropriate treatment.
Defibrillation, fixed mode pacing, ECG monitoring via pads/paddles, and other monitoring functions are not impacted by this issue.
The manufacturer will provide a hardware upgrade on all affected units. Users can continue to use MRx prior to receiving the hardware upgrade. If the above problem occurs, users should refer to the HeartStart MRx Instructions For Use for troubleshooting assistance and follow the technical advice as listed in the FSN.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 26 February 2014