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
    51120
  • Event Risk Class
    I
  • Event Initiated Date
    2013-04-11
  • 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 healthcare has become aware that the heartstart mrx monitor/defibrillator devices may fail to deliver defibrillation therapy in either manual defib or aed mode. if this occurs the mrx may simultaneously display a "no shock delivered" message along with a "shock equip malfunction" inop and a red x in the rfu indicator. in addition the pads ecg waveform may display a non-physiologic flat line rhythm.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Model / Serial
    Model Catalog: M3535A (Lot serial: >1000 numbers contact mfg); Model Catalog: M3536A (Lot serial: >1000 numbers contact mfg)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    HEARTSTART MRX DEFIBRLLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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