Events

Rappel de Volker LTC bed (with lateral release button for the side rails)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Iona Medical Products.

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-2016-RN-00835-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-30
  • 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-2016-RN-00835-1
  • 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
    Hill-rom has received notice that a side rail of a 2080 bed lowered unintentionally and abruptly when a patient leaned over the side rail with his full body weight. hill-rom have evaluated the potential risk and determined a likelihood of occurrence less than 9/100,000 units or 0.009%.Hill-rom would like to remind users of the bed rails of 2080 beds with lateral release buttons for the side rails of the proper use of side rails. if a patient needs to exit the bed, please lower the side rails and not directly load the rail with the full patient weight.
  • Action
    Hill Rom is advising users to ensure the bed rails are lowered before bed egress or patient assisted during egress of the bed. Hill Rom will be providing a service kit to be installed by a qualified service representative in order to correct the issue.

Device

Volker LTC bed (with lateral release button for the side rails)
  • Modèle / numéro de série
    Volker LTC bed (with lateral release button for the side rails)Model Number: 2080 FSSerial Number: 2080-2007-51-46ARTG Number: 96733
  • Manufacturer
    Iona Medical Products

Manufacturer

Iona Medical Products