Important Safety Alerts

The Australia Therapeutic Goods Administration (TGA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Philips HeartStart MRx Monitor/Defibrillator manufactured by Philips Medical Systems. According to the manufacturer, the affected devices are HeartStart MRx Monitors/Defibrillators with the following model and serial numbers:

• Model M3535A: US00100100 to US00576623
• Model M3536A: US00100902 to US00576650
• Model M3536J: US00209838 to US00332675
• Model M3536M: US00500002 to US00553553
• Model M3536MC: US00500001 to US00500087
• Model M3536M2: US00554176, US00554177, US00554178
• Model M3536M4: US00500003 to US00574869
• Model M3536M5: US00500001 to US00562935
• Model M3536M6: US00554358 to US00576619

The manufacturer has identified issues that could impact the safety and/or performance of certain MRx monitor/defibrillators described below:-

• Issue 1: The MRx can be susceptible to interference from electrical fast transients (EFTs) when connected to AC or DC power, operating with a LAN cable, or operating near a source of EFT interference, which could cause therapy to be delayed or delivered inadvertently.
• Issue 2: If a user undertakes certain atypical clinical workflows (ie, when using external paddles for defibrillation or when using the Periodic Clinical Data Transmission (PCDT) option on the MRx), the MRx can exhibit unexpected behaviour. These workflows do not correspond to instructions in the MRx Instructions for Use (IFU) and are not expected to be performed by trained clinicians. In addition, these device behaviours have only been observed during internal testing, and have not been reported during clinical use.
• Issue 3: The MRx could stop demand mode pacing due to an ECG leads-off condition when electrode-to-skin contact impedance values are outside design ranges for detection.

According to the manufacturer, the above issues will cause a delay in defibrillation therapy and/or an unintended shock to patient or users.

The manufacturer will implement a software upgrade for all units affected by one or more of the above issues.

The manufacturer advises users that they can continue to use their MRx prior to receiving the software upgrade, provided they follow the temporary workaround instructions provided in the customer letter.

For details, please refer to the following links:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2014-RN-01275-1
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON478819

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

Posted on 9 December 2014