Events

Retiro De Equipo (Recall) de Optional PS500 External Power Supply Unit Used in connection with Dräger V Series Ventilators

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-2014-RN-00989-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-15
  • 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-2014-RN-00989-1
  • 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
    Draeger has advised that in some cases in which the battery capacity of the optional ps500 power supply unity of the infinity acs workstation critical care (evita infinity v500) has reduced unexpectedly. the batteries in the ps500 were discharged prematurely, even though adequate battery charge status was displayed on the device. as a consequence of this, draeger published a safety alert in february 2014, as well as a safety recall and the suspension of deliveries for devices using the ps500.
  • Acción
    All PS500 Power Supply Units currently in use are in the process of being upgraded by the Dräger Service Engineers free of charge. A service-charging algorithm will be implemented, which prevents the problem of sulfation of the batteries, which was identified as a main reason for the reduction of the PS500 battery capacity.

Device

Optional PS500 External Power Supply Unit Used in connection with Dräger V Series Ventilators

Manufacturer

Draeger Medical Australia Pty Ltd