Events

Rappel de Meducore Easy Automatic External Defibrillator (AED) - Battery Pack

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par USL Medical 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-2017-RN-00281-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-05-02
  • 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-2017-RN-00281-1
  • 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
    An issue has been identified that in rare cases, the meducore easy battery pack may fail. in the event of failure, it would no longer be possible to administer a shock to the patient, which could lead to unsuccessful resuscitation.
  • Action
    USL Medical will be providing users with a replacement battery. Once the replacement battery is received, users are to immediately remove and discard the affected battery and insert the new battery into the device. Whilst waiting on the replacement battery, USL Medical recommends close monitoring of the status indicators on the front of the Meducore Easy AED to ensure battery and device readiness.

Device

Meducore Easy Automatic External Defibrillator (AED) - Battery Pack
  • Modèle / numéro de série
    Meducore Easy Automatic External Defibrillator (AED) - Battery PackBattery Pack Model Number: WM 40155Serial Numbers: 15120, 15122, 15127, 15121, 15119, 15126, 15118, 15117, 15116 & 15128ARTG Number: 214662
  • Manufacturer
    USL Medical Pty Ltd

Manufacturer

USL Medical Pty Ltd