Events

Rappel de Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bosco Medical Australia.

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-00429-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-11
  • 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-00429-1
  • 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 identified two issues relating to the power supply;- that the two halves of the power supply may come apart. if the two halves are not properly closed, there is a low risk of injury by electricity. as the conductive parts are secured by a fuse, severe injury is prevented. - the screw on domes for the housing of the power supply may break, and as a result, the housing itself may partially or completely come apart due to carious factors.It cannot be ruled out that the two issues may coincide and there is a low risk of injury by electricity.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Bosco has advised users to inspect power supply units for any defects. Any affected devices should be returned to Bosco for replacement with unaffected units. This action has been closed-out on 17/08/2016.

Device

Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)
  • Modèle / numéro de série
    Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)Model Number: 55-12-500Serial Numbers: 1506-CC02-0039, 1506-CC02-0040ARTG Number: 118226
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia