Events

Retiro De Equipo (Recall) de Aisys and Aisys CS2 Anaesthesia machines with the optional Vacuum Suction Function

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-00402-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-08
  • 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-00402-1
  • 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
    A potential safety issue has been identified with the optional vacuum suction function of certain devices within the aisys family of anaesthesia machines. the vacuum suction tubing could be kinked within the machine, resulting in suction less than the 20 lpm specified by iso 10079-3. if this issue is left unresolved, it could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient. this issue only impacts the vacuum suction option on certain aisys family devices. there is no impact on other performance characteristics of the anaesthesia machine. there have been no injuries reported as a result of this issue.
  • Acción
    GE Healthcare is advising users that all functions of the anaesthesia device can continue to be used. Users can continue to use the vacuum suction option if it has been evaluated against the minimum flow of 20 lpm as indicated above and with reference to the performance specification identified in the device URM (noted approximate maximum flow of 39 lpm). If the device does not pass the evaluation as being adequate, do not use for suction and ensure standalone suction is immediately available. This action has been closed-out on 02/02/2017.

Device

Aisys and Aisys CS2 Anaesthesia machines with the optional Vacuum Suction Function
  • Modelo / Serial
    Aisys and Aisys CS2 Anaesthesia machines with the optional Vacuum Suction FunctionMultiple Serial Numbers affectedARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd