Events

Recall of Powerheart G5s & G5A Automatic External Defibrillators (AEDs)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Cardiac Science Australia Pty 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-2014-RN-00109-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00109-1
  • 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
    Cardiac science has determined that certain powerheart g5 automatic external defibrillators (aeds) shipped between june 21, 2012, and march 1, 2013, may have been manufactured with a defective electrode connector. some of these g5 aeds have been found with missing spring contacts in the electrode connector assembly. when the spring is missing, the aed may not recognise that the pads have been placed on the patient during a rescue attempt. the aed voice prompts will progress until they reach the pads placement (peeled) step. at that point the aed will, regardless of whether the pads are placed onto the patient's chest or not, continuously repeat "place pads firmly onto patient's chest..." after 2 minutes, the pad placement prompting will time out and the aed will begin cpr mode. if the issue occurs, the aed may not be able to deliver therapy during a rescue attempt and may affect resuscitation of the patient. this could lead to serious adverse health events or death.
  • Action
    Cardiac Science is advising users that affected units will be required to be sent to Cardiac Science's head office for repair. Units will be returned to users the same day they are received by Cardiac Science. This action has been closed-out on 11/04/2016.

Device

Powerheart G5s & G5A Automatic External Defibrillators (AEDs)
  • Model / Serial
    Powerheart G5s & G5A Automatic External Defibrillators (AEDs) Model Number: G5A-31AMultiple Serial Numbers affectedARTG Number: 200242
  • Manufacturer
    Cardiac Science Australia Pty Ltd

Manufacturer

Cardiac Science Australia Pty Ltd