Safety Notice/Corrective action for HeartStart MRx (M3535A/M3536A), Philips Healthcare
2011.03.04
Product group Medical electronics / Electromedical devices
Reference 00874/11
Philips Healthcare has issued a Field Safety Notice concerning a corrective action of the defibrillator/monitor models HeartStart MRx M3535A and M3536A which are equipped with software version F.01.00 or F.01.01 and the hardware options End-tidal carbon dioxid (etCO2), Invasive Pressure (IP), Temperature (Temp) and Monitoring for Cardiopulmonary Resuscitation Q-CPR with the current generation CPR meter (part # 453564145481). The EtCO2 and Ventilation Rate values may be labelled incorrectly. Software versions F.01.03 and R.01.00 correct this problem.