Events

Safety Alert for heartstart frx, heartstart home, and heartstart onsite automated external defibrillators

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

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
    2018-03-14
  • Event Date Posted
    2018-03-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180314b.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 frx, heartstart home, and heartstart onsite automated external defibrillators the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning heartstart frx, heartstart home, and heartstart onsite automated external defibrillators (aeds), manufactured by philips. the manufacturer has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 aeds that were manufactured between 2002-2013. according to the manufacturer, virtually all of these resistor-related failures were detected through the device’s automatic self-testing, alerting the user by issuing audible chirps. the in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy. in the extremely rare circumstances, the automated tests fail to detect the aed’s inability to function normally, and fail to deliver a shock when one is needed, putting patients at risk of not receiving adequate therapy for their vf or vt, potentially resulting in serious injury, or even death. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-5-to-9-march-2018 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 march 2018.

Device

heartstart frx, heartstart home, and heartstart onsite automated external defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart FRx, HeartStart Home, and HeartStart OnSite automated external defibrillators
  • Manufacturer
    Philips

Manufacturer

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