Events

Rappel de Enterprise 8000 Electrical Bed

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-00105-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-02-21
  • 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-00105-1
  • 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 manufacturer has become aware of the potential for loose brake pedal screws (part number s1306) which are responsible for connecting the brake pedal with the base frame of the bed and keeping the brake in the correct position. this issue of loose screws is visible to users. there is no evidence to suggest that this anomaly is related with any potential risk to users.
  • Action
    Arjo is advising users to inspect the beds to determine if the screws are loose on the brake mechanism. If users see that the screw is not tightened fully, it means thatthe device is affected by this correction. Check the castor operation, paying attention to steering and/or braking function. If users detect small movements between the parts and loose movement between braking system, it means the device may be affected by this correction. Arjo will be inspecting the affected devices and replacing the affected screws during the next service visit. Users that undertake serving of their own devices are advised to unscrew the old screw S1306 and replace with new one, by use the torque wrench with 10.2 Nm torque.

Device

Enterprise 8000 Electrical Bed
  • Modèle / numéro de série
    Enterprise 8000 Electrical BedModel Numbers: 5000, 8000, 9000, E5000X, E8000X, E9000XARTG Number: 283224(Arjo Australia - Bed, general-purpose, electrical)
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA