Events

Retiro De Equipo (Recall) de Optional PS500 External Power Supply Unit used in connection with Dräger V Series Ventilators: Infinity V500; Babylog VN500; Evita V300

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-00610-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-08
  • 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-00610-1
  • 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 has become aware of an event in which the battery capacity of the optional ps500 did not last as long as expected. the batteries installed in the ps500 depleted much earlier than expected although the battery indicator showed a sufficiently charged battery. in 2014, dräger issued a measure regarding similar battery capacity failures within the ps500 external power supply unit. the root cause for that instance of the reduced battery capacity was due to an incorrect charging algorithm that subsequently caused sulfation within the battery. dräger have now identified that the new batteries supplied during this exchange may be affected by a manufacturing defect that could lead to shorter battery life times. the current analysis of the battery data available indicates that the charged battery will at least last for 30 minutes. in case of a main power loss, this 30 minutes battery back-up should typically be sufficient until the emergency main power supply is re-established.
  • Acción
    Affected customers will be contacted by Dräger representative to organise a battery exchange as soon as possible. Until the new batteries are installed Dräger is strongly recommending the following: - Do not rely on the battery status indicator. - If power fail alarm occurs, provide manual ventilation and immediately connect the ventilator to mains power to resume ventilation. - If the hospital’s Dräger ventilators are currently used for patient transport please contact Drager Service representative immediately so that these devices will be put on priority for the battery exchange. - Do not use the device for patient transports, unless absolutely necessary. This action has been closed-out on 22/08/2016.

Device

Optional PS500 External Power Supply Unit used in connection with Dräger V Series Ventilators: In...
  • Modelo / Serial
    Optional PS500 External Power Supply Unit used in connection with Dräger V Series Ventilators: Infinity V500; Babylog VN500; Evita V300Serial Number Range: all ARTG Numbers: 92177 & 170141 & 158739
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd