Events

Retiro De Equipo (Recall) de Hamilton Medical C3 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 The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

¿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-01134-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-29
  • 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-01134-1
  • 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 identified an issue related to spo2 monitoring with the use of the hamilton-c3 ventilator. when measuring spo2, the software of the hamilton-c3 can run into a system or cpu overload causing a screen freeze. the alarm buzzer sounds and the device needs to be reset. in case of such a system or cpu overload, the hamilton-c3 stops the ventilation and sounds the alarm buzzer. however, since the screen freezes, no alarm message is displayed to the operator. there have been no injuries reported as a result of this issue.
  • Acción
    All the Hamilton-C3 ventilators have SpO2 option deactivated by default as there are no SpO2 sensors in use in Australia. The new software version 2.0.2 will be installed as a permanent correction. This action has been closed-out on 15/02/2017.

Device

Hamilton Medical C3 Ventilator

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia