Events

Rappel de Defibrillator/pacer SLIM corpuls3

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-2014-RN-00979-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-15
  • 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-00979-1
  • 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
    Due to too little distance between a circuit board and the housing, there is the possibility that a component on that circuit board could be damaged mechanically. this impairs the radio connection between the modules. the user can recognise this, if a respective error message (ie, “no connection to defibrillator unit” or “no connection to p-box” ) is displayed. impairment of the radio connection between the modules could result in the inability to: - perform full patient monitoring; and - correctly adjust and operate a therapy function of the device. vibrations have been found to increase the likelihood of this malfunction. due to this issue, diagnosis and therapy are delayed, because the measurement and therapy functions cannot perform without problems.
  • Action
    Device Technologies Australia (DTA) is advising the customer to connect the module mechanically to form a compact device if the error message is displayed. A permanent correction of the error is only possible by replacing the affected radio module. DTA is arranging replacement of the radio module. This action has been closed-out on 1/06/2016.

Device

Defibrillator/pacer SLIM corpuls3

Manufacturer

Device Technologies Australia Pty Ltd