Events

Rappel de Infinity Acute Care Monitoring System (IACS) used with Kontron C500 Cockpit Kontron C500 Cockpits with revision index 06 or higher that contain 4GB RAM Modules

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-2017-RN-00735-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-06-08
  • 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-2017-RN-00735-1
  • 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
    Dräger has learned that dräger infinity acute care systems that use the newer kontron cockpits with revision index 06 or higher that contain 4gb ram modules may not annunciate audio or visual alarms on the cockpit and central station due to high memory usage. the infinity m540 will still issue both audible and visual alarms; the alarm function is not affected at the infinity m540 and infinity central station when the cockpit is disconnected. to date, dräger are not aware of any negative patient consequences arising from this issue.
  • Action
    Dräger will be contacting users to schedule a time to rework the identified devices by removing the affected Virtium RAM Modules and replacing them with the Swissbit version. In the interim, users are to remove the C500 Cockpit from service; the Infinity Acute Care System can be used without the C500 Cockpit as the Infinity M540 will function as the primary monitoring device once the Cockpit is disconnected.

Device

Infinity Acute Care Monitoring System (IACS) used with Kontron C500 Cockpit Kontron C500 Cockpits...
  • Modèle / numéro de série
    Infinity Acute Care Monitoring System (IACS) used with Kontron C500 CockpitKontron C500 Cockpits with revision index 06 or higher that contain 4GB RAM ModulesMultiple Cockpit Serial NumbersARTG Number: 168054
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd