Events

Retiro De Equipo (Recall) de Dräger Carina 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 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-2018-RN-00394-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-05-01
  • 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-2018-RN-00394-1
  • 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
    Draeger has been made aware that one component in the valve assembly of the carina ventilator was not sufficiently cleaned by a supplier. over time, this can result in the material of the valve assembly becoming corroded and can result in contamination of the breathing gas.This issue was identified during production at dräger. to date, no reports of adverse events have been received as a result of this issue.
  • Acción
    Draeger is advising customers to remove the potentially affected devices from use immediately to exclude any further risk to patients. Draeger will provide affected sites with loan devices to alleviate any delays and/or downtime. Draeger will contact users (via Engineering Department) to schedule the replacement of the affected components.

Device

Dräger Carina Ventilator
  • Modelo / Serial
    Dräger Carina VentilatorSerial Numbers: ASKM-0074; ASKM-0075; ASKM-0076; ASKM-0077; ASKM-0078; ASKM-0079; ASKM-0080; ASKM-0082; ASKM-0083; ASKM-0084; ASKM-0085; ASKM-0086; ASKM-0087; and ASKM-0088ARTG Number: 140966(Draeger Australia - Ventilator, adult)
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd