Events

Retiro De Equipo (Recall) de Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices installed from April 20, 2015 through October 2015. Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected

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-00038-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-12
  • 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-00038-1
  • 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
    The drive gas check valve of the affected devices could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle. if this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma. there have been no injuries reported as a result of this issue.
  • Acción
    The sponsor is advising users that the affected devices can continue to be used. In the event the reported issue does occur, the affected device provides alarms and there are automatic inherent safety mitigations by design to help ensure patient safety. The sponsor will contact users to arrange for an on-site correction. This action has been closed-out on 03/02/2017.

Device

Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 A...
  • Modelo / Serial
    Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices installed from April 20, 2015 through October 2015. Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affectedService kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000 and 1503-8101-000ARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd