Events

Retiro De Equipo (Recall) de Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed

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-2016-RN-01406-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-27
  • 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-2016-RN-01406-1
  • 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 become aware of a potential safety issue where certain avance cs2, avance and amingo anaesthesia devices can transition to a system malfunction state if the lower storage drawer containing the optional large tray insert accessory, is closed with an abnormally high amount of force. should the anaesthesia device transition to a system malfunction state the device will perform in the following manner:- automatically activate alternate oxygen flow within a few seconds,- provide high priority audible and visible alarms,- provide on display instructions to set the oxygen (o2) flow and manually ventilate the patient,- continue to deliver anaesthetic agent at the existing vaporizer setting.If the system malfunction is left unresolved, it could result in loss of patient ventilation potentially resulting in hypoxia. there have been no injuries reported as a result of this issue.
  • Acción
    GE is advising users that they can continue to use their Avance CS2, Avance, and Amingo devices after the optional large tray insert accessory has been removed. Customers are requested to destroy all large tray inserts in their possession.However, customers should contact GE if they choose to return the tray insert. This action has been closed-out on 18/05/2017.

Device

Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory ...
  • Modelo / Serial
    Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed Part Number of large tray insert : 1009-3260-000ARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd