Events

Safety Alert for heartstart mrx defibrillator/monitor m3536a and m3535a

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Medical Systems.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-03-17
  • Event Date Posted
    2017-03-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170317.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips medical systems heartstart mrx defibrillator/monitor m3536a and m3535a health canada has issued a medical device safety alert concerning heartstart mrx defibrillator/monitor [model number: m3536a and m3535a; all lots], manufactured by philips medical systems. the manufacturer has become aware of the following issues: if the pins that connect the battery to the device have become damaged or full of debris, the device may not power on or may repetitively reboot. when the device is unplugged from ac mains, it may enter a state where it will not charge for shock delivery or may unexpectedly cease pacing. for details, please refer to the health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2017/62658r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 march 2017.

Device

heartstart mrx defibrillator/monitor m3536a and m3535a
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Medical Systems HeartStart MRX Defibrillator/Monitor M3536A and M3535A
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH