Events

Retiro De Equipo (Recall) de Infinity Acute Care Monitoring System (IACS) with software version VG5.0 and Microstream (Patient monitoring system)

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-2016-RN-01412-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-11-01
  • 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-01412-1
  • 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
    Draeger have become aware of two issues with the use of iacs software version vg5.0, as follows:1. it is possible that expected audible alarms may not occur at both the iacs cockpit and m540 although the appropriate audible and visual alarms will occur at the infinity central station (ics) and appropriate visual alarms will occur from the iacs system. this audible alarming anomaly could lead to missing expected audible alarms from iacs. the ics alarms (visual and audible) as intended and lacs will still display visual alarms.2. microstream mcable co2, which is supported by software version vg5.0, displays the incorrect unit of measure (uom) in contradiction to the labelling. the monitor indicates that the uom is mmhg, however, the actual value presented is in % volume. the incorrect uom could contribute to an error in the interpretation of the presented value. all distributed devices will have this anomaly.There have been no injuries reported for the above issues.
  • Acción
    Draeger will be contacting customers to arrange for downgrade of the IACS System to software version VG4. In the interim, customers can continue to use IACS software version VG5.0 but only if it is used in connection with an ICS or there is constant supervision of visual alarms at the bedside. The Microstream MCable is not to be used. This action has been closed-out on 28/06/2017.

Device

Infinity Acute Care Monitoring System (IACS) with software version VG5.0 and Microstream (Patient...
  • Modelo / Serial
    Infinity Acute Care Monitoring System (IACS) with software version VG5.0 and Microstream (Patient monitoring system)ARTG Number: 168054
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd