Events

Rappel de DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system)

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-2012-RN-01222-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-12-05
  • 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-2012-RN-01222-1
  • 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
    There have been reported cases in which the displayed value for the invasive blood pressure measurement of the iacs was lower than the actual patient values were. investigations have shown that liquid ingress in the cable connection of the dualhemo mcable may cause inaccurate measurements. further investigation revealed that this can happen if the dualhemo mcable is used in a non-vertical position or vertically but top down instead of top up, or if it is simply laid down on the floor or on the patient bed and is not adequately positioned.
  • Action
    Drager Medical GmbH is providing an amendment to the instructions for use describing the correct orientation of the DualHemo Mcable when in use.

Device

DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system)
  • Modèle / numéro de série
    DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system)
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd