Events

Rappel de Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306M

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Trumpf Med Aust 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-2015-RN-00590-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-02
  • 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-2015-RN-00590-1
  • 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
    Trumpf medical has been notified of an incident where a motorised height-adjustable arm of a klinoport ceiling supply unit suddenly and abruptly fell to its lowest position. the cause analysis revealed that the welded connections of the drive did not comply with the specified condition and therefore led to breakage of these connections. it is currently not to be ruled out that further drives within the same serial numbers range may have the same fault. if further cases should occur, the risk of severe injury to persons cannot be ruled out.
  • Action
    Trumpf Medical will replace all potentially affected components in order to prevent a repetition of this incident. Until the correction can be made end users are advised to ensure that the unit is in the lowest position. Trumpf is recommending that a warning be placed on the device or the electrical fuse removed to ensure that the height of the arm is not adjusted. This action has been closed-out on 08/08/2016.

Device

Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306M
  • Modèle / numéro de série
    Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306MItem Numbers: 4027210, 4027410 and 4027510Serial Numbers: 100775185 to 101040245Only motorised height-adjustable arms are affected by this recall (recognisable by the letter "M" in the product name)
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd