Events

Rappel de Sidhil Inspiration Cot

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Midmed 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-00345-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-09
  • 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-00345-1
  • 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
    Following a period during which an active child had been left unattended in a 9003 inspiration cot the child was found by a consultancy paediatrician with his top wrapped around his head with the clothing hanging from the cots latch mechanism. the child had lifted up the tubing/cable access latch, which is located on the top rail at the head or foot end of the cot and managed to get his sleeve caught on the latch. upon trying to free himself the child managed to free his arms but was left with his clothing wrapped around his head, with the clothing still being caught on the top of the cot via the latch. the child was freed and no injuries were sustained.
  • Action
    Midmed is replacing the cable access cot ends with standard cot ends for all cots not used in critical care/intensive care.

Device

Sidhil Inspiration Cot
  • Modèle / numéro de série
    Sidhil Inspiration CotProduct Code: 9003ARTG Number: 167177
  • Manufacturer
    Midmed Pty Ltd

Manufacturer

Midmed Pty Ltd