Events

Retiro De Equipo (Recall) de Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor).

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

¿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-2012-RN-00805-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-08
  • 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-2012-RN-00805-3
  • 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
    The dash monitor may exhibit an unexpected loss of custom automatic nbp measurement cycling. custom automatic nbp measurement is a feature introduced in dash version 6.0 which allows the user to program up to 4 different nbp auto mode sequences. when a view of another patient with an nbp parameter on the network occurs, if the custom automatic nbp measurement cycling function is enabled, the function will turn off unexpectedly. the issue can occur when manually viewing another bed on the network using the view other beds option or automatically with the automatic view on alarm (avoa) feature.
  • Acción
    GE Healthcare is providing users with work around instructions to mitigate the issue. A software update will be implemented to permanently fix the issue when available.

Device

Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient m...
  • Modelo / Serial
    Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor).Monitors with software versions 6.0 and later may be affectedARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd