Events

Recall of HEARTSTART MRX DEFIBRILLATOR/MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    155048
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Model / Serial
    Model Catalog: M3535A (Lot serial: ALL); Model Catalog: M3536A (Lot serial: ALL)
  • Product Description
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC