Heartstart MRx Defibrillator/Monitor (2014-11-17)

Starting date:

November 17, 2014

Posting date:

December 11, 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-42797

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  Reason
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  Affected products

Recalled Products

Heartstart MRx Defibrillator/Monitor

Reason

Philips has become aware of three (3) issues that could impact the safety and/or performance of certain MRx Monitor/Defibrillators:

• Issue 1: The Heartstart MRx Defibrillator/Monitor 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 performs one of two atypical clinical workflows, the Heartstart MRx Defibrillator/Monitor can exhibit unexpected behaviour. These workflows do not correspond to instructions in the Heartstart MRx Defibrillator/Monitor instructions for use 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. The workflows and associated device behaviors are as follows:
  • Workflow A: when using external paddles for defibrillation, the device can deliver a shock when only one of the two shock buttons are depressed if the user performs a specific sequence.
  • Workflow B: when using the periodic clinical data transmission (PCDT) option on the MRx, the MRx can reboot if the user performs a specific sequence.
• Issue 3: the Heartstart MRx Defibrillator/Monitor 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.

Affected products