Important Safety Alerts

Health Canada posted a medical device safety alert concerning HeartStart MRx monitor/defibrillator (Model no.: M3535A, M3536A), manufactured by Philips Medical Systems.

According to the report, the manufacturer has become aware that affected devices may exhibit the following behaviors:

• In AED mode the device experiences difficulty interpreting pads ECG waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to analyze the waveform.
• In Manual mode the user may have trouble interpreting the pads ECG waveform and determining whether or not to deliver therapy in addition the devive may provide erroneous alarms (e.g. PVC/Min High, Vtach, Asystole) or indicate an asystolic rhythm when paddles are not in patient contact.
• If CPR meter is in use, users may not get an accurate impedance derived ventilation feedback.

For details, please refer to the Health Canada website
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_july-sept_2012-eng.php

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

Posted on 7 August 2012