Events

Rappel de Resmed Astral Batteries and Battery Packs

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par ResMed (Australia) 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
    20505
  • Date de mise en oeuvre de l'événement
    2016-08-16
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: ResMed (NZ) Ltd, 266 Runciman Road, Pukekohe, Auckland
  • Cause
    There have been a small number of occurrences (<0.1%) where an internal electrical fault has led to ventilation ceasing without either of the low battery alarms being activated. in all of these cases the total power failure alarm is activated as intended. this fault has also been reported with the astral external battery, however there have been no reports of cessation of ventilation.
  • Action
    Product to be exchanged

Device

Resmed Astral Batteries and Battery Packs
  • Modèle / numéro de série
    Model: , Affected: All Astral External Batteries, All Astral battery packs
  • Manufacturer
    ResMed (Australia) Ltd

Manufacturer

ResMed (Australia) Ltd