Events

Rappel de Maxi Air Blower Unit - Model 230V (a device designed as a stretcher that is intended for use together with a patient transfer lifting for lifting a patient who is moveable only in a horizontal lying position)

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-00560-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-29
  • 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-00560-1
  • 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
    The plastic enclosure used in the maxi air supply motor for models 230v is not fire retardant. this can be seen by the "arrows" on the moulded part and was confirmed by an ad-hoc flammability test. this may increase the risk of a fire spreading.
  • Action
    An ArjoHuntleigh representative will attend the affected hospital to replace the affected blower unit.

Device

Maxi Air Blower Unit - Model 230V (a device designed as a stretcher that is intended for use toge...
  • Modèle / numéro de série
    Maxi Air Blower Unit - Model 230V (a device designed as a stretcher that is intended for use together with a patient transfer lifting for lifting a patient who is moveable only in a horizontal lying position)Serial Numbers: S0112300, S0112299, S0102544ARTG Number: 215885
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

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