Corrective action for HeartStart MRx, Philips
2009.08.14
Product group Medical electronics / Electromedical devices
Reference 02693/09
Philips Healthcare has issued a Field Safety Notice concerning a corrective action of the monitor/defibrillator HeartStart MRx M3536A. In certain external transport use environments the mechanical/electrical connection between the pads therapy cable and the MRx may wear at an increased rate. Without routine checks, wear could ultimately prevent the device from sensing that the pads therapy cable is connected, or, cause the device to inappropriately identify it as external or internal paddles. The customers receive instructions for performing inspections which can find early indicators of this issue.
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