Events

Retiro De Equipo (Recall) de Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Ventilator)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Draeger Medical 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-2014-RN-00567-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-27
  • 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-2014-RN-00567-1
  • 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
    Drager has become aware of cases where prior to the use of the disposable ventstar oxylog 2000 ventilation hoses, adhesive residue the size of a finger nail was found loose in the hose or the packaging around the hose; had teh hose been used with the residue in place it may have entered the patient's lungs.
  • Acción
    Draeger is advising their customers to not use the hose system from the affected batches and to contact customer service to arrange for recovery and replacement.

Device

Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Venti...
  • Modelo / Serial
    Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Ventilator)Product Description: Packaging Box SetPart Number: 2M86841Batch Numbers: 330384.001 - 331661.002Product Description: Hose PackagingPart Number: 2M86791Batch Numbers: 330384.001 - 331661.002ARTG Number: 131796
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd