Events

Rappel de HeartStart Automated External Defibrillator (AED)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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-2013-RN-00087-2
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-01-31
  • 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-2013-RN-00087-2
  • 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
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA