Important Safety Alerts

Medical device manufacturer, Philips Medical Systems, has issued a medical device safety alert concerning its Heartstart MRx Defibrillator/Monitor. The affected products are as follows:-

• Model M3535A: Serial number US00100100 to US00578696
• Model M3536A: Serial number US00100902 to US00576650
• Model M3536J: Serial number US00209838 to US00332675
• Model M3536M: Serial number US00500002 to US00553553
• Model M3536MC: Serial number US00500001 to US00500087
• Model M3536M2: Serial number US00554176, US00554177, US00554178
• Model M3536M4: Serial number US00500003 to US00574869
• Model M3536M5: Serial number US00500001 to US00562935
• Model M3536M6: Serial number US00554358 to US00576619

The manufacturer has identified that under certain circumstances, the MRx monitor/defibrillator could reboot once in any operating mode if the following sequence occurs:

1. In Service Mode, the Status Log is cleared
2. Prior to exiting Service Mode, the MRx generates an entry in the Status Log.
3. MService Mode is exited.

The MRx is then in a state that could trigger a reboot at an indeterminate time. A reboot during the application of therapy or pacing could potentially cause interrupted pacing or a delay of defibrillation or cardioversion therapy. The MRx will restart within 8 seconds.

The manufacturer advises that affected users can continue to use the devices prior to receiving the software upgrade.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 31 December 2014