Events

Safety Alert for heartstart fr3 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
    2012-03-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120306b.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
    Field safety notice: heartstart fr3 automated external defibrillators the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning heartstart fr3 automated external defibrillators (aeds) manufactured by philips healthcare. the affected model numbers were 861388 and 861389 and distributed between may 24, 2011 and september 13, 2011. the software on aeds distributed during this time period requires an update, in order to address two urgent aspects. the first can, in an estimated one of 21,000 power cycles, leave the device in an activated but unresponsive state and thus not available for use when needed in an emergency unless the battery is removed and reinstalled. the second can result in a language loaded onto the fr3 that is different than the language selected by the user during the language load process. the manufacturer will provide an fr3 software update kit to correct the above two aspects. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm according to the local supplier, the affected device has not been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

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

Manufacturer

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