Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning automated external defibrillator (AED) HeartStart Home and Onsite (HS1) with model numbers M5066A and M5068A. The affected products were manufactured in July 2013.
According to the manufacturer, in a limited number of HeartStart Home and OnSite (HS1) AEDs, one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
The manufacturer will replace the affected AEDs for their customers. Meanwhile, users are advised to keep the AEDs in service if there are no alternative defibrillators readily available.
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