Events

Rappel de Powerheart G5s & G5A Automatic External Defibrillators (AEDs)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Cardiac Science Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00109-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00109-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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)
  • Modèle / numéro de série
    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