Events

Retiro De Equipo (Recall) de Carescape Monitor B850, all software versions (mutliparameter 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-00807-3
  • 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-00807-3
  • 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
    Ge healthcare has recently become aware of potential issues with the carescape monitor b850 as outlined below:1. carescape monitor b850 udom failure. it is possible that the carescape monitor b850 may enter into a constant book loop causing monitor to reboot continuously. 2. carescape monitor b850 unstable usb communication. when the usb cable is connected to the cpu or display is insecurely connected or faulty, the monitor may reboot. reboot may also happen if the monitor display is continuously set on and off several times. 3. carescape monitor b850 remote printing issue with currently printing prn 50 recorder. if the recorder prn 50 is busy when the carescape monitor b850 sends a printing request, the printing may not be saved and therefore not printed.4. carescape monitor b850 reboots due to an x server freeze.
  • Acción
    GE Healthcare will be implementing a software and hardware correction.

Device

Carescape Monitor B850, all software versions (mutliparameter patient monitor)
  • Modelo / Serial
    Carescape Monitor B850, all software versions (mutliparameter patient monitor)ARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd