Medical device manufacturer, Philips, has issued a medical device safety alert concerning its HeartStart MRx Monitor/Defibrillator with Q-CPR. The affected devices are identified as follows:-
During internal review, the manufacturer identified that the instructions on attaching the Q-CPR meter adhesive pad to the Q-CPR meter could be improved. In addition, instructions did not inform the users that properly performed CPR can result in injuries to the patient.
The manufacturer has updated the HeartStart MRX's Instructions for Use associated with Q-CPR sensor via an addendum. The addendum has instructions on application of the disposable adhesive pads, which are used with the Q-CPR meter, including a diagram which illustrates proper placement and orientation of this pad. In addition, the addendum includes general information on the types of injuries, which may occur during CPR.
According to the local supplier, the Q-CPR meter and CPR sensor are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 September 2015