Events

Retiro De Equipo (Recall) de eVent Medical Inspiration LS & i Series Ventilator Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

¿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-01059-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-10-28
  • 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-01059-1
  • 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
    Investigations have identified that a component on the systems power board can fail in a manner which can cause the ventilator to shut down without the alarm being triggered. this failure could result in death or serious injury to a patient.
  • Acción
    Users should discontinue use of the affected ventilators immediately until correction is completed. The manufacturer, eVent Medical has identified a correction to this issue which requires removal of the potentially faulty component from the power board. The corrective action will be undertaken by Taleb Medical during the month of November 2015. This action has been closed-out on 17/08/2016.

Device

eVent Medical Inspiration LS & i Series Ventilator Systems

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia