Events

Retiro De Equipo (Recall) de MetaVision ICU version 6.0x - 6.9x

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-2017-RN-01173-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-13
  • 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-2017-RN-01173-2
  • 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 received a complaint stating that there was a malfunction with the metavision icu system that resulted in specific medication doses missing in multiple patient files. after an analysis of this complaint, imdsoft determined that:- one patient did not receive some specific planned doses that were prescribed. the problem in the software also identified to occur for few other patients, but in their case no actual doses were skipped. no grave patient outcomes have been reported.- the cause was found to be a software malfunction in the metavision code which affected the behaviour of the order management driver (omd) - part of the metavision icu medication management module. the software malfunction resulted in an unnoticed omd failure which did not create specific medication doses of medication orders exceeded the horizon of 7 days per treatment plan. this led to the non-provision of specific medication doses to several patients.
  • Acción
    1. Complete the supplied Customer Response and return it by email to FSN@imd-soft.com. 2. Contact iMDsoft Customer Support on 1800 240 919 to arrange a software upgrade to correct the problem.

Device

MetaVision ICU version 6.0x - 6.9x
  • Modelo / Serial
    MetaVision ICU version 6.0x - 6.9xARTG Number: 165518
  • Manufacturer
    IMDsoft

Manufacturer

IMDsoft
  • Source
    DHTGA