Events

Rappel de Compella Bariatric Bed System, Controllers and Air Surfaces

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hill-Rom 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-2016-RN-00745-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-08
  • 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-00745-1
  • 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 become aware of a potential issue with some compella air supply units and air surfaces. the compella air supply unit has been prone to inadequate pressure, which prevents the surface from achieving required settings for weight-based pressure redistribution. this also prevents the low air loss feature from operating. in addition, within the low air loss surface, a hose in the foot section is prone to kinking, which can impact airflow to the topper and prevent the proper adjustment of the air bladders to relieve pressure.
  • Action
    A Hill-Rom representative will be contacting affected facilities to make arrangements for updating the affected capital Compella Air Supply Units and air surfaces. In the interim, Hill-Rom recommends customers to continue to use the product as they normally would. The mattress system will provide an alarm in the event the Compella Air Supply Unit or Air Surface does not operate properly. This action has been closed-out on 18/05/2017.

Device

Compella Bariatric Bed System, Controllers and Air Surfaces
  • Modèle / numéro de série
    Compella Bariatric Bed System, Controllers and Air SurfacesModel Number: P7800ACompella ControllersProduct Number: P7810AManufactured between 25 March 2015 to 11 December 2015Compella Air SurfacesProduct Number: P642AManufactured between 25 March 2015 to 25 September 2015ARTG Numbers: 239273, 239274
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd