Events

Rappel de Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor)

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 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-2018-RN-00265-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-26
  • 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-2018-RN-00265-1
  • 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
    Drager has determined that when the infinity m540 patient monitor with software versions vg4.1 and below is used in combination with the infinity mcable mainstream c02 (m11.1) revision 16 sensor, the infinity m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. should the infinity m540 patient monitor reboot 3 times within a 10 minute period or less, the infinity m540 patient monitor will go into a fail-state, resulting in a resetting to factory defaults, losing patient settings and stored patient data.This issue only occurs with infinity cable revision 16. there have been no injuries reported as a result of this issue.
  • Action
    Drager is advising users to discontinue use the Infinity CO2 sensor, revision 16. Drager will be replacing all revision 16 cables with an earlier revision as an interim correction. A software update will be implemented as a long term correction.

Device

Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitorin...
  • Modèle / numéro de série
    Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor) Part Number: 6871950Serial Numbers: ASKJ-0016, ASKH-0285, ASKH-0287, ASKK-0180, ASKK-0323, ASKK-0381ARTG Number: 140750Draeger Australia - Carbon dioxide sensor cable
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd