Medical device manufacturer, Philips Healthcare, has issued a field safety notice concerning HeartStart MRx monitor/defibrillator. The affected units included all HeartStart MRx monitor/defibrillator manufactured prior to June 2012 and used in external transport and Emergency Medical Service (EMS) environments. The affected model numbers included: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, and M3536M6.

According to the manufacturer, when used in EMS environments, the mechanical/electrical connection (connector pins and/or port pins) between the pads/paddles therapy cable (including pads CPR therapy cable and external paddles cable) and the MRx therapy connection port may experience high levels of stress causing accelerated wear. Without routine periodic inspections and preventive action by users, accelerated wear of the connection could ultimately prevent the device from sensing that the pads/paddles therapy cable is connected. This wear also may cause the MRx to misidentify the pads therapy cable, external paddles, or internal paddles when they are connected to the therapy port which could result in a delay of therapy, incorrect energy delivered, spontaneous/unintended therapy energy discharge, shock to caregiver when delivering therapy, and/or interrupted pacing with lost capture and inability to regain cardiac recapture.

The manufacturer advised users to

• Read the attached HeartStart MRx Instructions for Use Addendum which describes how a user can identify wear, and immediately implement ongoing therapy connection inspection on all of MRx devices to detect wear from higher than expected levels of stress. If wear is detected, remove affected devices immediately from use and contact Philips to arrange for service.
• Replace therapy cables/external paddles every three years from the time they were initially placed into service or if they fail the inspection criteria in the attached Instructions for Use Addendum.

According to the local supplier, the affected devices were distributed in Hong Kong.

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

Posted on 17 July 2012