Events

Recall of HeartStart FRx, HeartStart Home, and Heartstart OnSite

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-2018-RN-00229-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-05-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00229-1
  • 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 has become aware of a specific electronic failure with one of the resistors. virtually all of these resistor-related failures were detected through the devices’ automatic self-testing, alerting the user by issuing audible chirps. however, in rare instances, self-tests might not identify a problem and the device might not deliver a shock when needed. to date, philips is aware of 13 instances in which this component failed during treatment, out of more than 45,000 uses in which shock therapy was delivered. in all these instances, the device delivered at least one shock before failure. among the cases for which the patient outcome is known, in overseas jurisdictions, 5 patients died and 2 patients were successfully resuscitated and survived.The in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest patient is in need of shock therapy.
  • Action
    Upon receipt of the Customer Letter, users are asked to conduct a self-test on their device as per the instructions outlined in the current IFU using the details given below: • Check the pads label for the expiry date, replace if expired • Check the battery label for the expiry date, replace if expired • Depress the blue “i”, listen for the voice prompt to provide device status • Remove and reinsert the battery, allow the self-test to complete. Users are also requested to refresh their understanding of the Audible Chirps from the AED as detailed in the Customer Letter.

Device

HeartStart FRx, HeartStart Home, and Heartstart OnSite
  • Model / Serial
    HeartStart FRx, HeartStart Home, and Heartstart OnSiteAll AEDs manufactured between 2002 to 2013 (660,000 units )Possible R92 Resistor FailureARTG Number: 92346 (Philips Electronics Australia Ltd Defibrillator - Non-rechargeable public automated external defibrillator)
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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