Events

Rappel de LifePack 1000 Automated External Defibrillator (AED's), software version 2.42 or earlier

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Physio-Control 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-01036-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-10-26
  • 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-01036-1
  • 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
    As a follow-up to the previous communication in 2014 (tga ref: rc-2014-rn-00774-1), physio-control is correcting a software malfunction that may contribute to defibrillator batteries not being replaced when required.Physio-control australia has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock and deliver therapy.The operating instructions provided with the device may be confusing to some customers, which has contributed to customers not replacing their battery when required. also, a software malfunction in the lifepak 1000 defibrillator that also contributes to some customers not replacing their battery when required. this results in the readiness display indicating a low battery charge when it should indicate a very low battery charge.
  • Action
    Physio-Control will be implementing a software update in all affected devices over the next year. Updates to customer devices will be prioritised based on the age of the devices as well as the feedback provided in the response to the confirmation sheet attached with the customer letter. In the interim, customers are advised that it is critically important to understand what the device and battery indicators mean on the defibrillator and what actions needs to be undertaken. At any time the battery charge can be verified by the instructions provided in the Operating Instructions. Batteries that are at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the OK symbol is present.

Device

LifePack 1000 Automated External Defibrillator (AED's), software version 2.42 or earlier
  • Modèle / numéro de série
    LifePack 1000 Automated External Defibrillator (AED's), software version 2.42 or earlierAll lots affected ARTG Number: 138166
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

Physio-Control Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA