Events

Retiro De Equipo (Recall) de Infinity Acute Care Monitoring System (IACS) used with Kontron C500 Cockpit Kontron C500 Cockpits with revision index 06 or higher that contain 4GB RAM Modules

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-2017-RN-00735-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-08
  • 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-2017-RN-00735-1
  • 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
    Dräger has learned that dräger infinity acute care systems that use the newer kontron cockpits with revision index 06 or higher that contain 4gb ram modules may not annunciate audio or visual alarms on the cockpit and central station due to high memory usage. the infinity m540 will still issue both audible and visual alarms; the alarm function is not affected at the infinity m540 and infinity central station when the cockpit is disconnected. to date, dräger are not aware of any negative patient consequences arising from this issue.
  • Acción
    Dräger will be contacting users to schedule a time to rework the identified devices by removing the affected Virtium RAM Modules and replacing them with the Swissbit version. In the interim, users are to remove the C500 Cockpit from service; the Infinity Acute Care System can be used without the C500 Cockpit as the Infinity M540 will function as the primary monitoring device once the Cockpit is disconnected.

Device

Infinity Acute Care Monitoring System (IACS) used with Kontron C500 Cockpit Kontron C500 Cockpits...
  • Modelo / Serial
    Infinity Acute Care Monitoring System (IACS) used with Kontron C500 CockpitKontron C500 Cockpits with revision index 06 or higher that contain 4GB RAM ModulesMultiple Cockpit Serial NumbersARTG Number: 168054
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd