Events

Retiro De Equipo (Recall) de Drager V Series Ventilator with the Optional PS500 External Power Supply Unit 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-2017-RN-00176-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-02-06
  • 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-00176-1
  • 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 became aware that the battery capacity of the optional ps500 power supply unit was unexpectedly reduced. this resulted in batteries prematurely discharging, even though an adequate battery charge status was displayed. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. the reported issue may cause unexpected loss of automatic ventilation functionality.Further to the recall for product correction in feb 2016 (tga ref.: rc-2016-rn-00154-1), dräger has now developed device modifications to rectify the issue.
  • Acción
    The device modifications include the following:  - Installation of a new software 2.50 with improved battery charge management  - Improved charge management for external batteries  - Option of performing a battery check to determine the battery's current runtime  - Option of displaying the remaining battery capacity in minutes  - Installation of an additional internal backup battery  - Replacement of the power supply unit to support both the external battery and an additional internal battery  - Replacement of the existing external batteries. The installation of a backup battery will ensure that the internal battery will continue to supply power should the external battery fail. Users are advised to continue to observe the information in the Feb 2016 letter until the devices have been updated with the improved system.

Device

Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installed
  • Modelo / Serial
    Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installedAffected Models: Infinity V500; Evita V300; and Babylog VN500 All Serial Numbers affectedARTG Numbers: 158739, 170141 and 92177
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd