Events

Retiro De Equipo (Recall) de Drager V Series Ventilator with the Optional PS500 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-2016-RN-00154-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-02-10
  • 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-00154-1
  • 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
    The battery capacity of the optional ps500 power supply unit for the evita infinity v500, evita infinity v300 and the babylog vn500 rapidly and unexpectedly reduces despite using the most recent power supply firmware (fw1 .50) which was released in november 2015 .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 which could lead to serious injuries to the patient. so far no injuries have been reported.
  • Acción
    The sponsor is cancelling the distribution of the updated power supply firmware (FW1.50) and rolling back devices on which this firmware version is already installed to FW1.49. As a preventive measure, Dräger will replace the batteries of all PS500 customers every 6 months until a permanent technical solution is available. Dräger is also advising users NOT to use the device for patient transport unless absolutely necessary and NOT to rely on the battery status indicator.

Device

Drager V Series Ventilator with the Optional PS500 Installed
  • Modelo / Serial
    Drager V Series Ventilator with the Optional PS500 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