Events

Retiro De Equipo (Recall) de All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015

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-2015-RN-01233-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-12-21
  • 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-2015-RN-01233-1
  • 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
    If the clear patient history prompt is not responded to, the previous patient's weight could be displayed on the giraffe carestation user interface.This could cause clinical decisions to be made based on the weight associated with the wrong patients, which in turn could lead to clinical decisions which could require medical intervention.There have been no injuries reported as a result of this issue.
  • Acción
    GE Healthcare is providing work around instructions for users to follow as an interim measure. A software upgrade will be provided as a permanent correction. This action has been closed-out on 29/08/2016.

Device

All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015
  • Modelo / Serial
    All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015Giraffe Incubator Carestation Serial Numbers: TAAU67001, TAAU67002, TAAU67003, TAAU67004, TAAU67006, TAAU67007, TAAU67011, TAAU67012Giraffe OmniBed Carestation Serial Numbers: TABU67001, TABU67002, TABU67003, TABU67005, TABU67006, TABU67007, TABU67008, TABU67009, TABU67011 ARTG Number: 139289
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd