Events

Retiro De Equipo (Recall) de CARESCAPE Monitor B650 Software Versions: 1.1.12.26 or earlier

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-00594-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-29
  • 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-00594-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue due to possible sound loss associated with the carescape monitor b650. when an external display is connected to the carescape monitor b650 using a usb extender cable with an active usb hub, the system may experience a sound loss including alarm sounds from the patient monitor. this may occur if the external display is powered off and on during normal operation of the monitor.
  • Acción
    GE is advising their customers that this issue can be avoided by not switching the external display off and then switching it back on during normal monitor use and by not using a USB extender cable with active hub. If the sound loss occurs during normal operation of the monitor, users can enable the sounds back on by restarting the monitor. A software patch will be provided to correct this issue permanently.

Device

CARESCAPE Monitor B650 Software Versions: 1.1.12.26 or earlier

Manufacturer

GE Healthcare Australia Pty Ltd