Events

Rappel de iMDsoft MetaVision ICU (MV-ICU), Version 5.47.4622(graphical patient information system used for data collection, management, and storage)

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-2016-RN-00188-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-02-22
  • 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-2016-RN-00188-1
  • 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
    A software issue has been identified in the medication management module which may lead to duplication of medication dose under specific settings. this can only occur when a medication order has a weekly interval (e.G., administer medication x every monday) and an attribute (e.G, dose quantity or frequency) of the order is subsequently modified.
  • Action
    A temporary mitigation was provided by means of modifying the software configuration setting. Specifically, the proposal was to extend the time horizon from 7 days, which is equal to the dose interval, to greater than 7 days. A permanent solution will be provided once it becomes available.

Device

iMDsoft MetaVision ICU (MV-ICU), Version 5.47.4622(graphical patient information system used for ...
  • Modèle / numéro de série
    iMDsoft MetaVision ICU (MV-ICU), Version 5.47.4622(graphical patient information system used for data collection, management, and storage)ARTG Number: 165518
  • Manufacturer
    IMDsoft

Manufacturer

IMDsoft
  • Source
    DHTGA