Events

Rappel de Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000X, Enterprise 9000X, Citadel and Citadel Plus

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Huntleigh Healthcare 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-2017-RN-01199-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-12
  • 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-2017-RN-01199-1
  • 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
    Arjo huntleigh has received customer complaints regarding the failure of gas spring (damper index no. 828.760) which did not support the safety sides properly. as a result, when safety sides are being lowered, the dampers do not slow down the movement of the side rail. in these circumstances, the dampers do not provide the correct distance between panels and the frame of the bed to ensure no entrapment of fingers.
  • Action
    ArjoHuntleigh will be in contact with users to arrange replacement of affected gas dampeners. In the interim, users are advised to refer to the IFU for details regarding processes for safe side rail lowering, including steps that the rail should be held until completely lowered.

Device

Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000...
  • Modèle / numéro de série
    Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000X, Enterprise 9000X, Citadel and Citadel PlusSerial Number Range: P0183010 – P0469078ARTG Number: 283224(Arjo Australia - Bed, general-purpose, electrical)
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA