Events

Rappel de AvantGuard 1600 Li160A0(Hospital 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 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-00253-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-03-08
  • 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-00253-1
  • 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 reports that the backrest actuator on the avantguard 1600 beds may experience a jolted motion, noise (clanking or chattering), premature wear, or backrest functionality loss when a load is applied to the backrest section. these issues do not affect the cpr functionality in case of emergency.The reported issue is unlikely to cause adverse health consequences.
  • Action
    Hill-Rom has developed a correction and will contact the affected facilities to modify the affected beds. The CPR function is still operational in case of emergency. For this reason, the device can continue to be used whilst awaiting the correction. If however, the unit experiences a loss of backrest functionality, users are advised to take it out of service and contact Hill-Rom.

Device

AvantGuard 1600 Li160A0(Hospital bed)
  • Modèle / numéro de série
    AvantGuard 1600 Li160A0(Hospital bed)Models: CS160A0005XXX & PRS160A0005XXXSerial Numbers: HRP001288830 to HRP002497322Manufactured between June 2009 and December 2015.ARTG number: 127268
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd