Events

Retiro De Equipo (Recall) de Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 April 2013 to 22 July 2013

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-00953-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-11
  • 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-00953-1
  • 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 involving unresponsive buttons on the display of the engstrom ventilator and the aespire view, aisys and avance anaesthesia machines. as a result of a manufacturing issue, the buttons on the left, right and bottom keypads may not always detect button presses. this may result in the inability to access certain menu functions which could possibly lead to delay in treatment.
  • Acción
    The user may notice that a button press may not actuate the desired function. Usually by pressing the key again, the device will respond as expected. If a button has no response, the menu function may be accessible through the use of the control wheel. If none of the above steps can be performed, discontinue use and contact a GE Healthcare Service Representative. GE Healthcare will correct all affected systems.

Device

Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 Apr...
  • Modelo / Serial
    Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 April 2013 to 22 July 2013Multiple serial numbers affectedARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd