Events

Rappel de Quickie Q7 Manual Wheelchair

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Sunrise Medical 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-00892-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-07
  • 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-00892-1
  • 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
    It has been identified that over time, and under some usage conditions, the backrest brackets may break and detach from the chair frame. if a backrest bracket breaks and goes unnoticed by the user or care giver, there is a risk that the occupant could fall out of the seat and sustain injury to the head or lower back. the expected failure rate of the issue is 1.75%. there have been four reported injuries as a result of users unexpectedly falling from the seats. if a backrest bracket breaks and goes unnoticed by the user or caregiver, there is a risk for the occupant to fall out of the seat and sustain an injury to the head or lower back.
  • Action
    Consumers will be contacted by the dealer who supplied the device to arrange replacement of affected backrest brackets. Sunrise Medical is providing dealers with a replacement bracket kit to be installed on all affected wheelchairs. Wheelchairs manufactured after 27 November 2013 are unaffected by this issue. For more details, please see https://www.tga.gov.au/alert/quickie-q7-manual-wheelchair .

Device

Quickie Q7 Manual Wheelchair
  • Modèle / numéro de série
    Quickie Q7 Manual Wheelchair Model Number: EIR4Serial Number Range: R4-007239 to R4-022394Manufactured between 1 September 2009 and 27 November 2013ARTG Number: 100167
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd