Events

Retiro De Equipo (Recall) de Dräger Oxylog Transport Ventilators - Oxylog 3000 and Oxylog 3000plus

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-01617-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-12-14
  • 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-01617-1
  • 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
    In dec 2015, dräger informed users of an error condition observed with the oxylog 3000 / oxylog 3000plus (tga ref.: rc-2015-rn-01256-1), where the loss of contact of one of the control knobs generated an error message (previously referred to as "poti unplugged"). in these cases, acoustical and visual alarms are triggered, the breathing system releases pressure & the ventilation function stops operating. investigations indicated that the error condition was caused by an oxide layer in the potentiometer. these oxide layers may accumulate over a longer period of time where various factors collude (i.E. if the knobs are moved rarely or never). as communicated previously, a verified remedy is repeated twisting of the knobs that removes the oxide layer. whilst the remedy of twisting the knob is still considered effective, to reduce the impact of this error condition dräger has developed new software.
  • Acción
    Dräger has developed a new software that reduces the impact of the error condition i.e., software version 1.06 will be introduced for the Oxylog 3000plus and software version 1.23 for Oxylog 3000 respectively. A Dräger engineer will contact affected customers directly to schedule the software upgrade. Whenever a "control knob faulty" condition will occur with a device being equipped with the new software, the device will continue to ventilate with the last valid settings, display for example the values for tidal volume in case of a defective potentiometer for VT and post the corresponding alarm. As reflected in the amended Instructions for Use Manual, users are advised to check the patient’s condition and the ventilation.

Device

Dräger Oxylog Transport Ventilators - Oxylog 3000 and Oxylog 3000plus
  • Modelo / Serial
    Dräger Oxylog Transport Ventilators - Oxylog 3000 and Oxylog 3000plusAll Serial NumbersARTG Number: 169507
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd