URGENT – Medical Device Correction for Philips HeartStart MRx Monitor

Philips has identified the possibility of abnormal device behaviors on the HeartStart MRx Monitor/Defibrillator. Under exceptionally rare circumstances, the device may exhibit the following behaviors:

  1. If the pins that connect the battery to the device have become damaged or full of debris, it could result in a poor electrical connection. The device may not power on or may repetitively reboot when on battery power only.
  2. After unplugging the device from AC mains, when operating with a single battery as the sole source of power, there are two abnormal behaviors of the HeartStart MRx Monitor/Defibrillator that may occur:
    1. After the user depresses the charge button, the device attempts to charge, and after approximately 20 seconds, generates the “Shock Equipment Malfunction” error message and is unable to deliver shock therapy.
    2. Pacing may cease without warning. These device behaviors continue until the unit is reset.

Either potential problem could potentially delay monitoring or therapy.

The purpose of this Field Safety Notice is to inform you about the:

  • Issues and under what conditions they can occur
  • Actions that you should take to prevent risks for patients
  • Corrective actions planned by Philips to address the issues

Please review the following information with all members of your staff who should be aware of the contents of this communication. Please retain a copy with the equipment Instructions for Use.

The following pages provide information on how to identify affected devices and instructions on actions to be taken. Follow the “ACTION TO BE TAKEN BY CUSTOMER I USER” section of the notice. To address this correction, Philips is:

  1. Providing an Instructions for Use (IFU) Addendum. This Addendum describes how users can check the battery connection pins in order to avoid the device from failing to power on or repetitively reboot.
  2. Providing measures to prevent, or methods to allow the user to correct, the abnormal device behavior related to charging and pacing after disconnecting the device from AC mains.

This voluntary correction has been reported to the appropriate regulatory agencies.

Philips apologizes for any inconvenience this may cause you. If you have questions regarding this notification or need any further information or support, please contact your local Philips representative or call us at 1-800-722-9377.

Affected Models Include

Product: Philips HeartStart MRx Monitor/Defibrillator model numbers

PRODUCTS M3535A, M3536A, and military bundles.

Units Affected:

  • M3535A
  • M3535ATZ
  • M3536A
  • M3536ATZ
  • M3536M
  • M3536MC
  • M3536M2
  • M3536M3
  • M3536M4
  • M3536M5
  • M3536M6
  • M3536M7
  • M3536M8
  • M3536M9