The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning certain models of HeartStart MRx Monitor/Defibrillators [Model no.: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6], manufactured by Philips Healthcare. The affected units include those manufactured by Philips between February 2004 and May 2013, and with serial numbers between US00100100 to US00567299.
A Philips HeartStart MRx Monitor/Defibrillator could deliver a non-synchronised cardioversion shock when the user rotates the Therapy Knob while simultaneously pressing the Sync button, then charges the MRx and presses the shock button. Delivery of a non-synchronised cardioversion shock could result in the delivery of incorrect therapy, which may induce ventricular fibrillation.
Additionally, the label affixed to the top of the MRx device is not consistent with the Instructions for Use.
The manufacturer is providing work around instructions as an interim measure. A software update and device label revision will be supplied to users as a permanent fix.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00622-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 June 2013