Events

Rappel de Prism Medical P300 and C300 Lifts

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Rehab Assist 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-2015-RN-00967-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-30
  • 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-2015-RN-00967-1
  • 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
    Prism has been made aware of 17 incidents involving 300 series lifts in which the drive gear shaft has broken, eliminating the lifts ability to raise or lower a patient. of these 17 incidents we have discovered 3 in which the free fall protection system did not engage properly. if both of these incidents occur atthe same time there is a risk for the person being supported by the lift to drop unexpectedly. the patients involved in the 3 incidents were not seriously injured and did not require medical attention.
  • Action
    Rehab Assist will replacing the affected units with a new unit. For further information please see https://www.tga.gov.au/alert/prism-medical-p300-and-c300-ceiling-hoist. This action has been closed-out on 18/08/2016.

Device

Prism Medical P300 and C300 Lifts
  • Modèle / numéro de série
    Prism Medical P300 and C300 LiftsLifter P300Models: 303050; 303051Serial: P303470 – 479, P304158/164/171/172, P304536 – 539, P304866/867, P305116/118, P305125 – 127, P305130/134/135Lifter C300Models: 330050; 330053Serial: C303221/224/225, CQ303107 – 116Lifts manufactured prior to 8 June 2015ARTG Number: 169639
  • Manufacturer
    Rehab Assist Pty Ltd

Manufacturer

Rehab Assist Pty Ltd