Events

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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por IMDsoft.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00188-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-02-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00188-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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 ...
  • Modelo / Serial
    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