Heartstart MRx Defibrillator/Monitor (2014-12-16)

Starting date:

December 16, 2014

Posting date:

December 30, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-43029

• 
  Reason
• 
  Affected products

Recalled Products   

Heartstart MRx Defibrillator/Monitor 

Reason

Philips has become aware that the Heartstart MRx Defibrillator/Monitor 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 device generates an entry in the status log.
3. Service mode is exited.

The Heartstart MRx device is then in a state that could trigger a reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed. The Heartstart MRx device will restart within 8 seconds.

Note: if a reboot occurs during clinical use, current device settings and patient record are retained.

*the status log is a tool accessed by service personnel. It includes entries for all messages logged during normal operating mode, automated tests, service and configuration mode, and operational checks. The Heartstart MRx defibrillator/monitor service manual instructs service personnel to clear the status log after successful completion of an operational check.

Affected products