Events

Rappel de Hill-Rom MC700 General Ward 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-2014-RN-00537-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-13
  • 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-2014-RN-00537-1
  • 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 found that some of the hill-rom mc700 general ward beds, manufactured between the dates specified, may experience problems with the brakes; if the brake system is not fully engaged upon activation, the brakes may become disengaged when the bed is shaken. this can result in unwanted bed movement, and possible patient or caregiver injury.
  • Action
    Hill-Rom is advising their customers to ensure that beds are monitored for brake malfunction. If a brake malfunction is observed remove the bed from service. Hill-Rom is currently working on a long term correction which will be installed on all affectd beds once complete. This action has been closed-out on 17/08/2016.

Device

Hill-Rom MC700 General Ward Bed
  • Modèle / numéro de série
    Hill-Rom MC700 General Ward BedSerial Numbers: 006505 to 009144Manufactured from Jan 2012 to Feb 2014ARTG Number: 170974
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd