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
    18267
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-15
  • 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 that when heartstart mrx defibrillator monitors are used in external transport and ems environments the mechanical/electrical connection between the pads/paddles therapy cable (including pads cpr therapy cable and external paddles cable) and the mrx therapy connection port may experience higher than expected levels of stress causing accelerated wear. without routine periodic inspections and preventive action by users wear of the connection could ultimately prevent the device from sensing that the pads/paddles therapy cable is connected. this wear also may cause the mrx to inappropriately identify the pads therapy cable external paddles or internal paddles. pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers.

Device

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

Manufacturer

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