Events

Retiro De Equipo (Recall) de Babytherm 8004/8010 and Babytherm 8000WB for newborns (Infant warmers and open infant care units)

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-00961-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-09
  • 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-00961-1
  • 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 have become aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guide and was not completely locked. the side panel did not open during this incident and no patient was affected. as part of the review, dräger identified that the inner 70mm panels were not always used however, the inner 70mm panels are part of the safety concept of the babytherm 80xx. if contrary to the information provided in the instructions for use manual the inner panels are not inserted and if a side panel has not been fully locked into position this may allow the baby’s movements to open the side panel. it may be possible for a child to fall out.
  • Acción
    Users are reminded to pay attention to the information provided in the Instruction for Use Manual: i.e., “Check that the side panels lock securely into position and that they remain securely locked”. If the locking mechanism is not functioning or the inner panels are missing or damaged, please contact Dräger Customer Service to arrange correction. This action has been closed-out on03/02/2017.

Device

Babytherm 8004/8010 and Babytherm 8000WB for newborns (Infant warmers and open infant care units)
  • Modelo / Serial
    Babytherm 8004/8010 and Babytherm 8000WB for newborns (Infant warmers and open infant care units)ARTG Number: 121161
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd