Events

Recall of HeartStart Automated External Defibrillator (AED)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00087-2
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00087-2
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Philips is providing additional instructions for use to advise the user of the correct actions to take in the event an error notification:-if the frx or hs1 aed emits a pattern of 'single chirps' please press the blue i-button on the front of the device. the aed will tell exactly what actions to take to ensure that the device is ready for use. -if at any time during the life of the device, the frx or hs1 aed emitted or begins to emit a pattern of 'triple chirps', it is important that the device is removed from use and a philips representative is contacted. it is a signal that the device requires investigation by philips to ensure that it is ready for use.
  • Action
    Philips is providing additional instructions advising users to contact Philips technical support if a device error occurs and the device begins to emit a triple chirp, even if the error can be cleared.

Device

HeartStart Automated External Defibrillator (AED)

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA