Events

Rappel de MetaVision ICU (MV-ICU) Version 5.47

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par IMDsoft.

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-2015-RN-00860-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-02
  • 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-2015-RN-00860-1
  • 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
    Imdsoft has identified a software bug in metavision 5.47 which appears when switching between patients or users. it can cause a refresh error which has the potential to cause confusion to healthcare providers reviewing patient information. this bug can lead to the title bar reflecting the previous patient details while the remainder of the patient data on screen refreshes, this causes a data mismatch and an error message to occur. the message presents the user with an option of 'retry’ or 'ignore'. if the user chooses 'ignore' it allows the data mismatch to continue.
  • Action
    Until a permanent solution is available, users are advised to choose 'abort' should they see this error occur which causes a system restart and forces a data refresh, in parallel with their routine Patient Identification processes. Users are advised that when they move between patients or change users that they must check to ensure the patient matches the patient information on the title bar of the application. It is anticipated that a new version of the MetaVision software which fixes the software bug mentioned above will be released on 20 September 2015 and will be then available for installation. This action has been closed-out on 17/08/2016.

Device

MetaVision ICU (MV-ICU) Version 5.47
  • Modèle / numéro de série
    MetaVision ICU (MV-ICU)Version 5.47
  • Manufacturer
    IMDsoft

Manufacturer

IMDsoft
  • Source
    DHTGA