Events

Retiro De Equipo (Recall) de Carescape Monitor B650 (Multi parameter 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-00806-3
  • 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-00806-3
  • 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
    1) spo2 saturation limit alarm does not always activate when nellcor spo2 is used in pdm and saturation seconds is not switched on.2) when the carescape monitor b650 is started the monitor may enter into a constant boot loop causing monitor to reboot continuously.3) when the carescape monitor b650 is connected to the unity id and information from a 3-lead ecg cable is transferred through dri (s/5) network, the monitor may reboot.4) upgrading the software for carescape monitor b650 may not update the software for power management card (pmc).5) when the usb cable connected to the carescape monitor b650 is insecurely connected or faulty and is able to move the monitor may reboot. 6) carescape monitor b650 remote printing issue with currently printing prn 50 recorder.7) carescape monitor b650 reboots due to an x server freeze. it may reboot when the monitor is viewed from carescape cic pro or when the printing is initiated from carescape cic pro.
  • Acción
    GE Healthcare is providing users with work around instructions to mitigate the issue. A software and hardware update will be implemented to permanently fix the issue when available.

Device

Carescape Monitor B650 (Multi parameter patient monitor)

Manufacturer

GE Healthcare Australia Pty Ltd