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-2015-RN-01256-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-12-23
  • 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-2015-RN-01256-1
  • 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
    Some cases have been reported to draeger in which the "poti unplugged" error message was generated. in those cases an audible and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating. the error message is caused by increased electrical contact resistances of the controllers (setting potentiometers). the increased resistance is caused by an oxide layer that has formed on the controller over a lengthy period of time. no patient injury has been reported due to this issue.
  • Acción
    The oxide layer can only form if the controllers are rarely or never moved and according to product monitoring, some users never, or rarely, use the FiO2 controller. As a preventative measure to ensure the resistance taper of the controllers are sufficiently cleaned, Draeger is recommending the following addition to the daily device check: - Prior to turning on the Oxylog in readiness to conduct the daily device check, the staff member turns each of the controllers (Vt, RR, Pmax and FiO2) to the right and left stop positions (minimum and maximum values) at least ten times each. - The Oxylog can then be turned on and the onboard device check completed.

Device

Oxylog Transport Ventilator

Manufacturer

Draeger Medical Australia Pty Ltd