Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning automated external defibrillator (AED) HeartStart FR3 with model numbers 861388 and 861389. The affected products were manufactured from May to August 2013.
According to Philip Healthcare, HeartStart FR3 2.0 device software contains a defect which, in unlikely situations, may cause a unit to indicate that it is ready for use though its battery is low.
An AED running affected software may not report its low battery condition until the unit is turned on, and consequently may be unable to maintain the power needed to deliver therapy in an emergency.
The manufacturer advises users of the followings:
According to the local supplier, the affected products were distributed to Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 07 March 2014