Events

Safety Alert for HeartStart FRx and HeartStart HS1 automated external 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
    2013-12-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131204a.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
    Press release
  • Reason
    Safety alert on philips heartstart frx and heartstart hs1 automated external defibrillators the department of health (dh) today (december 4) drew the public's attention to a safety alert issued by philips healthcare concerning its three models of automated external defibrillators (aeds), namely heartstart frx, heartstart hs1 home and heartstart hs1 onsite, as the devices may be unable to deliver the needed electric shock in a cardiac emergency situation. the dh, through its routine surveillance on medical devices, noticed the above alert from the us food and drug administration. according to philips healthcare, the devices manufactured between 2005 and 2012 could incorrectly indicate that they are ready for use yet be unable to deliver the needed electric shock. according to the local supplier, philips electronics hong kong ltd, the affected models are marketed in hong kong as heartstart frx and heartstart hs1. the dh's enquiries with the supplier revealed that 374 units of heartstart frx and heartstart hs1 have been distributed to hospitals, clinics, schools and other venues. a dh spokesman said, "all owners of the affected aeds are advised to contact their supplier for technical support and advice. they should keep the affected aeds in service until such advice or a replacement is available." "so far, the dh has not received any relevant reports of adverse incidents related to the affected aeds in hong kong," the spokesman added. the company has set up a customer service hotline, 800 969 619, to answer related enquiries. the dh has informed public and private hospitals and relevant associations about the alert and shall continue to liaise with the supplier on the follow-up actions. ends/wednesday, december 4, 2013 issued at hkt 20:46.

Device

HeartStart FRx and HeartStart HS1 automated external defibrillators
  • Model / Serial
  • Product Description
    Press release: Safety alert on Philips HeartStart FRx and HeartStart HS1 automated external defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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