Events

Retiro De Equipo (Recall) de Drager V Series Ventilator with the Optional PS500 battery Installed

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-2015-RN-01150-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-11-25
  • 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-2015-RN-01150-1
  • 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
    This recall is due to the unexpected shortening of the optional ps500 battery on an iacs workstation critical care unit. the batteries were discharged early, even though the device was indicating an adequate battery state of charge. the devices generate a "battery low" alarm, followed by "battery flat". in exceptional cases, the "battery flat" alarm might be displayed too late, or not at all. after complete discharge of the batteries, the device correctly alerts to failure of the power supply by the auxiliary alarm (piezo, power failure alarm) in all cases. it has been discovered that the current design of the charging algorithm for the new ps500 batteries is not able to appropriately prevent premature battery ageing in all application scenarios.The unexpected loss of automatic ventilation functionality due to depleted battery requires immediate user intervention to prevent serious patient harm, including death. no patient injuries have been reported so far.
  • Acción
    The sponsor Draeger is advising users not to use devices with the affected PS500 battery unit for patient transport until the firmware has been updated.

Device

Drager V Series Ventilator with the Optional PS500 battery Installed
  • Modelo / Serial
    Drager V Series Ventilator with the Optional PS500 battery InstalledAffected models:Infinity V500Babylog VN500Evita V300All serial numbers affectedARTG Numbers: 158739, 170141 and 92177
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd