Events

Retiro De Equipo (Recall) de Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)

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-00098-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-06
  • 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-00098-1
  • 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
    It has been identified that specific combinations of engstrom ventilator casters and bases pose an increased likelihood of failures of the caster mounting hardware. a failure of the caster mounting hardware may result in the ventilator falling/tipping (overbalancing). a fall/tip of the engstrom ventilator can result in serious injury to patients or clinical staff.
  • Acción
    GE is replacing all affected accessory carts. End users are advised that they can continue to use the cart until replaced, however the casters must be checked for signs of damage and loosening. This action has been closed-out on 03/08/2016.

Device

Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as p...
  • Modelo / Serial
    Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)Serial Numbers: CBCN01062 through CBCQ01396ARTG Number: 108308
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd