Events

Retiro De Equipo (Recall) de Dräger Babytherm Infant Warmer

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-00794-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-06-15
  • 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-2016-RN-00794-1
  • 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 a case in which a babytherm 8004 without patient was operated in skin temperature mode with skin temperature sensor to prepare it for use. ln skin temperature mode, the radiant warmer output is controlled automatically until the set skin temperature is reached. as a result of operating the temperature sensor without patient contact, the radiant warmer was operated continuously at a high output ievel. during this forced continuous operation under high thermal ioad, the heater element aged faster. a part became detached from the heater element and fell onto the mattress tray where a towel caught fire. dräger's investigation revealed that the instructions for use do not contain explicit hints/warnings that refer to this misuse. additionally, dräger's analyses have shown that the heater elements are not replaced at regular intervals as recommended in the babytherm instructions for use.
  • Acción
    Dräger has amended the Instructions for Use Manual for new devices, and is providing users with a supplement which contains additional warnings and following additional instructions: - Do not operate the device in skin temperature mode with temperature sensor without patient contact - lf the heating elements have been in operation for more than 2 years, please replace them. Customers are advised to distribute the notice to all departments with the Babytherm Infant Warmer; models 8004; and/or 8010 within their facility. This action has been closed-out on 20/02/2017.

Device

Dräger Babytherm Infant Warmer

Manufacturer

Draeger Medical Australia Pty Ltd