Events

Rappel de Drager Infinity Acute Care System (IACS) Monitoring Solution with software versions VG2.2 to VG6.0 and the Infinity M540 Stand-Alone Patient Monitor with software versions from VG2.2 to VG6.0

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-00154-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-03-13
  • 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-00154-1
  • 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 is placed in standby mode and the user simultaneously connects the infinity mcable- dual hemo or infinity mpod quad-hemo to the infinity m540 patient monitor and then proceeds to zero the invasive pressure channel, in rare cases the invasive pressure visual and audible alarms are not activated. although the invasive pressure value displayed on the infinity m540 patient monitor and on the infinity medical cockpit is accurate, the invasive pressure visual and audible alarms will stay disabled until the patient is discharged or the hemodynamic pod is disconnected and reconnected.This issue is not seen when the user puts the m540 into stand-by mode, and then connects the hemodynamic pod in a sequential manner. the actual ibp measurements, and the patient values are correctly displayed on both the m540 and cockpit at all times.
  • Action
    Drager is advising users to follow the below identified steps whenever the Hemodynamic Pod is plugged into the Infinity M540 Patient Monitor and the unit is placed in Standby. When users are ready to monitor the patient: 1. Exit Standby Mode 2. Unplug, pause for a minimum of 3 seconds and re-plug the Hemodynamic Pod 3. Continue per the normal procedure. Drager will be performing a software update as a permanent correction.

Device

Drager Infinity Acute Care System (IACS) Monitoring Solution with software versions VG2.2 to VG6....
  • Modèle / numéro de série
    Drager Infinity Acute Care System (IACS) Monitoring Solution with software versions VG2.2 to VG6.0 and the Infinity M540 Stand-Alone Patient Monitor with software versions from VG2.2 to VG6.0All models affectedARTG Numbers: 168054 and 98600
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd