Events

Retiro De Equipo (Recall) de Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor)

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 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-2018-RN-00265-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-26
  • 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-2018-RN-00265-1
  • 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
    Drager has determined that when the infinity m540 patient monitor with software versions vg4.1 and below is used in combination with the infinity mcable mainstream c02 (m11.1) revision 16 sensor, the infinity m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. should the infinity m540 patient monitor reboot 3 times within a 10 minute period or less, the infinity m540 patient monitor will go into a fail-state, resulting in a resetting to factory defaults, losing patient settings and stored patient data.This issue only occurs with infinity cable revision 16. there have been no injuries reported as a result of this issue.
  • Acción
    Drager is advising users to discontinue use the Infinity CO2 sensor, revision 16. Drager will be replacing all revision 16 cables with an earlier revision as an interim correction. A software update will be implemented as a long term correction.

Device

Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitorin...
  • Modelo / Serial
    Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor) Part Number: 6871950Serial Numbers: ASKJ-0016, ASKH-0285, ASKH-0287, ASKK-0180, ASKK-0323, ASKK-0381ARTG Number: 140750Draeger Australia - Carbon dioxide sensor cable
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd