Events

Rappel de Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare 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-01266-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-04
  • 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-01266-1
  • 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
    Following an internal investigation triggered by reports in the field, it was identified that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. in such a situation the inability to defibrillate or a delay in doing so can as a consequence lead to the death or severe injury of the patient. this potential malfunction can occur with these electrodes after a duration of storage of about 2 years or more.
  • Action
    Customers are advised to quarantine affected lot numbers and return for replacement This action has been closed-out on 24/05/2016.

Device

Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
  • Modèle / numéro de série
    Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillatorsProduct Codes: 2059144-001 & 2059144-005 (DF69, 50461)Lot numbers: 21003-0770, 21113-0777 & 21220-0771ARTG number: 208134
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd