Health Canada — Medical Devices · Canada · 2014-03-25 · Type II
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Reported risk: Philips has become aware that when used in hospital transport and pre-hospital (EMS) environments, the connection between the pads/paddles therapy cable (including pads CPR therapy cable, external paddles cable, and internal paddles cable/adapter) and the MRX therapy connection port could experience high levels of stress causing accelerated wear. Wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. This wear also could cause the MRX to inappropriately identify the pads therapy cable, external paddles, or internal paddles. Pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers.
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