Events

Rappel de Entroy Pool Lifter

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Arjo Australia 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-2018-RN-00230-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-26
  • 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-2018-RN-00230-1
  • 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
    Arjo have identified a potential for the chair or stretcher detachment from entroy pool lifter. it is identified that this issue is caused by a potential misalignment that might be unnoticed by the caregiver so the seat/stretcher does not get fully paired with the pin. instead, once the lift reaches certain height, the seat/stretcher falls off the lift. there are one or more possible reasons that can lead to such a situation to occur: - maintenance checks not performed properly,- users do not recognize the poor connection,- pool lift owners does not recognise that the product needs maintenance, - wear on the docking connection causes the pin to hit the edge of the pairing cylinder instead of entering it.
  • Action
    Arjo are advising users that they will arrange for an on-site service technician visit to install a Quick Reference Guide, which is an illustration-based instruction, which users may refer to ensure a patient transfer is conducted as indicated in the IFU.

Device

Entroy Pool Lifter
  • Modèle / numéro de série
    Entroy Pool LifterModel Number: GAB1000-x01Affected Serial Numbers 810000957 up to T3387 ARTG: 230595Arjo Australia - Lift, patient transfer, stationary
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA