Events

Retiro De Equipo (Recall) de PS500 External Power Supply Unit used 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-00165-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-18
  • 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-00165-1
  • 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 batteries installed in the ps500 deplete much earlier than expected although the battery indicator showed a sufficiently charged battery. in some cases neither the “battery low” nor the “battery depleted” alarm was given, when the remaining battery capacity fell below 10%. available data indicates that the charged battery will last for at least 3 minutes. in case of a main power loss, this 3 minute battery back-up should typically be sufficient until the emergency main power supply is re-established.
  • Acción
    Draeger is advising users to only use the affected device for transport if absolutely necessary and users should not rely on the battery status indicator. Draeger is recommending users have a breathing bag available for manual ventilation as per the Instructions for Use (IFU). Draeger is advising that if the power fail alarm occurs during transport, provide manual ventilation and immediately connect the ventilator to wall power to resume ventilation. Draeger is advising that the batteries on all affected devices will be replaced as an interim correction, until a permanent fix can be developed.

Device

PS500 External Power Supply Unit used with Dräger V Series Ventilators

Manufacturer

Draeger Medical Australia Pty Ltd