Rappel de Monitor AC3000 Spring Arm (component of Draeger ceiling pendant and light systems)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger Medical 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-2013-RN-01239-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-28
  • Pays de l'événement
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
  • 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 a case in which the monitor support bracket has detached from the joint pin at the bottom of the height adjustable ac3000 spring arm and fallen down together with the monitor until it was only held by the electrical cable connections. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. investigation showed that the support shoulder of the locking element in the aluminum pin's groove is too low in an unfavorable tolerance position. the frequent movement of the arm under load may cause the locking element to damage the pin's groove and ultimately shear off, which may then result in the reported event.
  • Action
    Drager is advising users that the monitor arms will be inspected and repaired if required. Drager is also providing instructions to be followed by technically trained personnel, and will provide the required locking elements for replacement.

Device

  • Modèle / numéro de série
    Monitor AC3000 Spring Arm (component of Draeger ceiling pendant and light systems)Part Numbers: G92756 and G94499ARTG Number: 132260
  • Manufacturer

Manufacturer