Events

Rappel de Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011

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-2013-RN-00762-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-24
  • 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-2013-RN-00762-1
  • 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
    During investigations by arjohuntleigh it has been determined that the din connector used on these beds has been compromised during the cable manufacturing process. the supplier has determined that liquid droplets have been found inside the male din connector. this substance has been identified as phosphorous that is leaching from the black plastic flame reduction material used in the din connector. the effects of this can lead to a high resistance (ohm) connection between the pins and could result in the beds performing uncommanded movements.
  • Action
    Customers are requested to remove beds from use and contact the ArjoHuntleigh Service Line immediately if at any time a Contoura 380 or 480 bed performs uncommanded movement. An ArjoHuntleigh Technician will attend each facility to replace any defective DIN connectors. DIN Connectors with production batch date of October or November 2010 will need to be replaced. DIN Connectors with production batch date of January 2011 and February 2011 will undergo a Megger test which will determine if the connector needs to be replaced. This action has been closed-out on 19/05/2016.

Device

Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011
  • Modèle / numéro de série
    Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011ARTG Number: 205117
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

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