Events

Rappel de Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system) Software versions VG2.03 and higher are affected

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-01162-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-12
  • 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-2013-RN-01162-1
  • 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 found that if a low spo2 yellow medium grade alarm is displayed and paused by the user, the iacs did not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit and the central station; only the patient monitor (m540) showed the red signal. the correct spo2 value is indicated on all devices. this iacs behaviour happens only in the neonatal mode.
  • Action
    Draeger Medical is recommending users not to pause the medium grade SpO2 low alarm without adequate patient surveillance. A software update is being developed as a permanent fix and should be available in March 2014.

Device

Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system) Software versio...
  • Modèle / numéro de série
    Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system)Software versions VG2.03 and higher are affectedMultiple serial numbers affectedARTG Number: 168054
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd