Events

Rappel de Concerto & Basic Shower Trolleys (used for assisted hygiene care)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Huntleigh Healthcare 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-00500-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-28
  • 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-00500-1
  • 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
    As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a limited number of complaints where the bolts under the stretcher became loose. there has been one minor injury as a result of a patient falling related to these incidents. arjohuntleigh investigated the issue and concluded the stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher–tilt function may not engage properly, resulting in a patient falling to the floor.
  • Action
    ArjoHuntLeigh is advising users to ensure the trolleys are checked regularly as per the Instructions for Use (IFU). ArjoHuntLeigh will be performing an inspection on all affected devices to ensure the bolts are securely fastened. This action has been closed-out on 16/02/2017.

Device

Concerto & Basic Shower Trolleys (used for assisted hygiene care)
  • Modèle / numéro de série
    Concerto & Basic Shower Trolleys (used for assisted hygiene care)Serial Numbers: 3000846870, 3000852015, 3000856697, 3000856697, 3000856697, 3000646121, 3000674706, 3000674706, 3000676859, 3000674706,3000717577, 3000717577, 3000720597, 3000720597, 3000756366, 3000766008, 3000783964, 3000783964, 3000783964 Manufactured between 7 March 2014 and 20 April 2015ARTG Number: 199958
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA