Events

Retiro De Equipo (Recall) de Oxylog 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-00168-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-18
  • 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-00168-1
  • 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
    The manufacturer has received reports of devices displaying the error message “poti unplugged”.The investigation has revealed that a limited batch of control panel pcbs - onto which the potentiometer for setting the ventilation parameters is soldered, is faulty. this can result in the contact to the respective potentiometer being interrupted. the device then discontinues ventilation, gives an audible alarm and displays the error message poti unplugged. if this error occurs the user must immediately commence ventilation using an independent ventilator (manual ventilation bag) as specified in the instructions for use manual.
  • Acción
    Draeger are recommending users commence manual ventilation as specified in the Instructions for Use (IFU) if the error occurs. Draeger will be contacting all affected users to organise the correction of the affected devices.

Device

Oxylog Transport Ventilator
  • Modelo / Serial
    Oxylog Transport VentilatorModels: Oxylog 3000plus and Oxylog 2000plusSerial Numbers: ASEJ-0138, ASEK-0011ARTG Number: 169507
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd