Events

Rappel de Iris Hi Lo Bed(adjustable electric bed)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Pride Mobility Products 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-2017-RN-00842-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-31
  • 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-00842-1
  • 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
    The tga has determined that the side rails supplied with this bed do not comply with the below listed standard and that there is a resulting risk of patient harm, including but not limited to patient entrapment:iec 60601-2-52:2009: medical electrical equipment - part 2-52: particular requirements for the basic safety and essential performance of medical beds while no safety-related incidents have been reported to date, pride australia has, as a precautionary measure have agreed to undertake a recall for product correction.
  • Action
    Pride, requests that users immediately remove the existing side rails in the event they are installed on the bed. To enable you to remove the existing side rails, Pride have supplied a leaflet of instructions demonstrating how to remove the side rails, along with the Customer Letter as an attachment. Please follow the instructions given to facilitate this recall action.

Device

Iris Hi Lo Bed(adjustable electric bed)

Manufacturer

Pride Mobility Products Australia Pty Ltd