Events

Retiro De Equipo (Recall) de Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000)

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-00155-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-28
  • 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-00155-1
  • 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 identified several potential safety issues with the dash 3000/4000/5000 patient monitors and the dash port 2 docking station.The dash 3000/4000/5000 patient monitors may encounter the following issues:- dash stops communicating on the unity network resulting in loss of monitoring at the carespace cic pro central station.- dash displays distorted ecg waveforms in combination monitoring mode- dash date reverts to 1993the dash port 2 stops communicating on the unity network resulting in loss of monitoring at the carespace cic pro central station.
  • Acción
    GE Healthcare is developing a software correction and will provide to customers once development has been completed. In the interim end users have been requested to follow work around instructions to help mitigate the issues. Thia action has been closed out on 28/01/2016.

Device

Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000...
  • Modelo / Serial
    Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000)Dash networked units with product codes EH, AAB, DSH, SBG, SHQ and SD0 in the serial number Dash Port 2 units with product code SE5 in the serial numberARTG number 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd