Events

Rappel de Corpatch Easy Paediatric (defibrillator electrodes)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2015-RN-00388-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-07
  • 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-2015-RN-00388-1
  • 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 internal investigation showed that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this malfunction can occur with defibrillation electrodes that are older than 2 years. 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. the precise cause for this is still under investigation. the electrodes are being in used in connection with the defibrillators corpuls 08/16, corpuls1 and corpuls3. other defibrillation electrodes manufactured for the corpuls defibrillators are not affected by the problem.
  • Action
    Device Technologies Australia (DTA) is requesting their customers to isolate the affected electrodes. DTA is contacting the customers with a Good Return Authorisation (GRA) number and arrange collection. Replacement paediatric leads are available and will be provided as soon as possible. In the interim, if no paediatric defibrillation electrodes are available, DTS advises that standard adult electrodes may be used for defibrillation of patients <25kg. This action has been closed-out on 08/08/2016.

Device

Corpatch Easy Paediatric (defibrillator electrodes)
  • Modèle / numéro de série
    Corpatch Easy Paediatric (defibrillator electrodes)Product Code CP-5120.2 Lot Numbers: 30708-0777, 30822-0778, 31009-0773, 31121-0774, 40107-0771, 40213-0774, 40222-0773, 40320-0770, 40321-0770, 40324-0773, 40522-0779, 40704-0776, 40808-0773, 40923-0776, 41021-0778.ARTG number: 200520
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd