Events

Retiro De Equipo (Recall) de MetaVision ICU (MV-ICU) Version 5.47

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-2015-RN-00860-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-02
  • 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-2015-RN-00860-1
  • 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
    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.
  • Acción
    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
  • Modelo / Serial
    MetaVision ICU (MV-ICU)Version 5.47
  • Manufacturer
    IMDsoft

Manufacturer

IMDsoft
  • Source
    DHTGA