Events

Retiro De Equipo (Recall) de Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system) Software versions VG2.03 and higher are affected

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-2013-RN-01162-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-12
  • 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-2013-RN-01162-1
  • 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 found that if a low spo2 yellow medium grade alarm is displayed and paused by the user, the iacs did not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit and the central station; only the patient monitor (m540) showed the red signal. the correct spo2 value is indicated on all devices. this iacs behaviour happens only in the neonatal mode.
  • Acción
    Draeger Medical is recommending users not to pause the medium grade SpO2 low alarm without adequate patient surveillance. A software update is being developed as a permanent fix and should be available in March 2014.

Device

Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system) Software versio...
  • Modelo / Serial
    Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system)Software versions VG2.03 and higher are affectedMultiple serial numbers affectedARTG Number: 168054
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd