Events

Retiro De Equipo (Recall) de Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function 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-2014-RN-00114-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-05
  • 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-2014-RN-00114-1
  • 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
    The solar 8000m/i automatic view on alarm (avoa) feature will stop functioning if the patient monitor is discharged from the cic central station while a remote automatic bedside alarm view is currently being displayed on the solar. once this issue occurs, subsequent remote avoa alarms will not automatically appear on the left side of the solar display. in addition, the user interface menus on the discharged patient monitor will not function correctly. this may result in delayed treatment due to missed alarms that may be serious. this issue can be fixed by rebooting the solar 8000m/i.Parameter, waveforms and alarms associated with the patient directly connected to the solar 8000m/i patient monitor are not affected.
  • Acción
    GE Healthcare is advising users that if patients are discharged from the CIC central station to discontinue use of the AVOA feature and is providing instructions to disable the feature. If patients are not discharged from the CIC central station the AVOA feature can continue to be used. This action has been closed-out on 29/01/2016. GE Healthcare will be implementing a software upgrade for all Solar 8000i / M monitors.

Device

Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function pati...
  • Modelo / Serial
    Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function patient monitor)ARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd