Events

Safety Alert for automated external defibrillator heartstart fr3

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
    2014-03-07
  • Event Date Posted
    2014-03-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140307a.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 healthcare automated external defibrillator heartstart fr3 medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning automated external defibrillator (aed) heartstart fr3 with model numbers 861388 and 861389. the affected products were manufactured from may to august 2013. according to philip healthcare, heartstart fr3 2.0 device software contains a defect which, in unlikely situations, may cause a unit to indicate that it is ready for use though its battery is low. an aed running affected software may not report its low battery condition until the unit is turned on, and consequently may be unable to maintain the power needed to deliver therapy in an emergency. the manufacturer advises users of the followings: if users have an affected device, they should remove it from service. users should upgrade all affected fr3 units according to the instructions in the fr3 software upgrade kit. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 march 2014.

Device

automated external defibrillator heartstart fr3
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Healthcare Automated External Defibrillator HeartStart FR3
  • Manufacturer
    Philips Healthcare

Manufacturer

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