Events

Recall of HEARTSTART MRX DEFIBRILLATOR/MONITOR - BATTERY/POWER MODULE

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
    97296
  • Event Risk Class
    II
  • Event Initiated Date
    2009-12-01
  • 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
    With regard to accessories for the heartstart mrx portable external defibrillator (m5528a - mrx vehicle wall mount and m5529a - dc power module) it was determined that under certain conditions a smoke or fire hazard to patients or caregivers in proximity to the vehicle wall mount could occur. this happens only when both the vehicle wall mount and dc power module are installed together and if the user modifies the product. more specifically it was found this only occurs if the user modifies the dc output cable from either the dc power module and/or the electrical connector on the wall mount by cutting/splicing or soldering.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR - BATTERY/POWER MODULE
  • Model / Serial
    Model Catalog: M5529A (Lot serial: ); Model Catalog: M5528A (Lot serial: )
  • Product Description
    HeartStart MRx DC Power Module
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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