Important Safety Alerts

Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning certain models of HeartStart MRx Monitor/Defibrillators [Model no.: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5 and M3536M6]. The affected units include those manufactured by Philips between February 2004 and February 2013, and shipped worldwide with serial numbers within the ranges US00100100 and US00565942.

A Philips HeartStart MRx Monitor/Defibrillator operating on battery power only that is used in-hospital or in pre-hospital environments may shutdown without warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and continuous repetitive power line bursts. Examples of other equipment that can cause interference are other medical devices, cellular products, information technology equipment and radio/television transmissions.

The manufacturer provides the following information and advice

• The condition can be avoided by operating the device on external AC or external DC power.
• When using battery power only, users should follow the device instructions to minimize or eliminate potential interference from other RF sources. See MRx IFU section, Safety Considerations, Emissions and Immunity for proper use of your MRx relative to electromagnetic emissions.
• If the device powers down and the battery fuel gauge lights appear off or dim, users should perform the following:
  • Remove any potential source of RF interference from the environment
  • Replace the battery with a fully-charged battery with five solid, bright green lights on the battery fuel gauge or connect an external power source

In addition, the manufacturer will provide an IFU Addendum titled "HeartStart MRx Electromagnetic Compatibility" for all customers with affected units.

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 14 June 2013