Events

Retiro De Equipo (Recall) de Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtel 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-00582-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-29
  • 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-2014-RN-00582-1
  • 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 monitored minute volumes (vmin) are reported at ten times actual value on the bedside monitor. the source of this error is associated with a change in the flexport communication protocol between versions 1.1 and 1.2. all alarms and setting levels on the bedside monitor continue to perform properly and are unaffected by this error. the reported x10 volumes would be an obvious error to the clinician.
  • Acción
    Medtel Australia is notifying their customers of the issue and advising that the ventilator performance is not affected. A software update will be implemented to correct the issue. This action has been closed-out on 12/02/2016.

Device

Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2
  • Modelo / Serial
    Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2Model Number: 90436A-07ARTG Number: 135706
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA