Health Canada — Medical Devices · Canada · 2014-03-21 · Type II
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Reported risk: Philips Healthcare has become aware that 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. Philips Healthcare will be providing all affected customers with an IFU addendum titled, Heartstart MRX electromagnetic compatibility.
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