Medical device manufacturer, Philips, has issued a medical device safety alert concerning its HeartStart MRx Monitor/Defibrillator. The affected products are identified as follow:
According to the manufacturer, if the HeartStart MRx Monitor/Defibrillator is dropped or subjected to a severe mechanical shock, the device may suffer internal damage even though the device did not have visible external damage or the Ready for Use (RFU) indicator unit does not immediately indicate a problem. Unless the user initiates a manual operational check as described in the Instructions for Use (IFU) immediately after the unit is dropped or mishandled, the device may not identify a fault and alert the user until the next scheduled automated self-test or operational check. A damaged unit may not be able to deliver therapy.
Affected users should be informed that if a HeartStart MRx Monitor/Defibrillator is dropped or subjected to severe mechanical shock and the exterior case is still intact, they should immediately perform an operational check as described in the IFU section "Performing the Operational Check" in the Maintenance Chapter. The unit should be taken out of service. Users should contact the manufacturer if the unit is visibly damaged or if the device fails the operational check, i.e., if the RFU indicator changes to a "red-X" or the device emits a periodic audible "chirp", as described in the IFU. The manufacturer is directing users to insert a copy of this notice with each copy of the HeartStart MRx IFU.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 March 2020