Events

Retiro De Equipo (Recall) de PDM module with Frame F5-01 used with CARESCAPE Monitor B850

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-2013-RN-01136-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-06
  • 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-2013-RN-01136-1
  • 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 pdm patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the f5-01 frame due to an issue with the pdm ethernet communication hardware. the communication loss may occur when the pdm is first attached to the host monitor, or it may lose communication spontaneously during use with no user action. communication is not automatically re-established. loss of communication with the host monitor results in a loss of monitoring for the parameters provided by the pdm module, however an audible and visual alarm will be displayed.
  • Acción
    GE Healthcare are providing work around instructions for users to follow. GE will be replacing the affected frames as a permanent correction. This action has been closed-out on 10/02/2016.

Device

PDM module with Frame F5-01 used with CARESCAPE Monitor B850

Manufacturer

GE Healthcare Australia Pty Ltd