Events

Safety Alert for heartstart mrx monitor/defibrillators

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

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
    2013-06-20
  • Event Date Posted
    2013-06-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130620a.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 heartstart mrx monitor/defibrillators the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning certain models of heartstart mrx monitor/defibrillators [model no.: m3535a, m3536a, m3536j, m3536m, m3536mc, m3536m2, m3536m4, m3536m5, m3536m6], manufactured by philips healthcare. the affected units include those manufactured by philips between february 2004 and may 2013, and with serial numbers between us00100100 to us00567299. a philips heartstart mrx monitor/defibrillator could deliver a non-synchronised cardioversion shock when the user rotates the therapy knob while simultaneously pressing the sync button, then charges the mrx and presses the shock button. delivery of a non-synchronised cardioversion shock could result in the delivery of incorrect therapy, which may induce ventricular fibrillation. additionally, the label affixed to the top of the mrx device is not consistent with the instructions for use. the manufacturer is providing work around instructions as an interim measure. a software update and device label revision will be supplied to users as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00622-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 june 2013.

Device

heartstart mrx monitor/defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH