Events

Retiro De Equipo (Recall) de Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2.7PN 7200

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical Technologies 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-00095-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-06
  • 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-00095-1
  • 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
    Medical technologies is informing end users of an extremely rare software problem. the problem is withinthe embedded software of the fabian hfo. fabian hfo devices may as a symptom exhibit a halting user interface (touchscreen and/or hard keys). if this happens, it will no longer be possible to adjust the parameter settings. the current ventilation parameters are maintained and there is no interruption to ventilation.
  • Acción
    In the event of this problem occurring, it is recommended to transfer the patient to an alternative ventilator. The fabian HFO can continue to be used ONLY in the event where no other ventilator is available in the facility as the single fault condition alarms in the event of a halting user interface, alerting the operator. All fabian HFO ventilators will be updated with software GUI 3.0.2.7 made available by Acutronic. This will prevent the described problem. In addition, Acutronic software has a new watchdog implementation that monitors the state of the serial communication. A failsafe mechanism triggered by watchdog will prevent further similar occurrences from happening. This action has been closed-out on 15/07/2016.

Device

Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2...
  • Modelo / Serial
    Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2.7PN 7200All serial numbers suppliedARTG Number: 185053
  • Manufacturer
    Medical Technologies Pty Ltd

Manufacturer

Medical Technologies Pty Ltd