Events

Retiro De Equipo (Recall) de Drager Ventstar Paediatric Circuit, used in conjunction with the Dräger Oxylog 3000plus 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-2016-RN-00721-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-05-27
  • 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-2016-RN-00721-1
  • 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
    During the course of routine internal testing drager detected isolated leakages at the check valve (one way valve of the inspiration branch) of the above mentioned disposable paediatric ventilation circuit. leakage at the check valve can result in a patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the exhaled gas with subsequent reduced oxygen concentration for the patient. this leakage is not detected during the ventilator operational readiness check. to date, drager has not received any complaints associated with this issue.Further detailed investigations have shown that the check valve functions properly with no leak observed at positive end-expiratory pressures above 5 mbar i cmh20. the problem only occurs at peep values below 5 mbar i cmh20.
  • Acción
    Drager urgently recommends that users immediately inspect any stock and dispose of any product (part number 5704964) with a date of manufacture up to and including 03-2016. A Free of charge replacement product can be obtained by following the instructions in the customer letter.

Device

Drager Ventstar Paediatric Circuit, used in conjunction with the Dräger Oxylog 3000plus Transport...

Manufacturer

Draeger Medical Australia Pty Ltd