Events

Retiro De Equipo (Recall) de Tecotherm Neo (a heating/cooling system for use with infants)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Innervate 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-00902-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-20
  • 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-00902-1
  • 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
    It has been identified that the self-test conducted immediately after switching on the device is evaluated as failed although everything would work correctly. users would see a message that says a serious internal malfunction has occurred and after 30 seconds the device would automatically switch off. this is a result of a defect with the main circuit board.
  • Acción
    Niche Medical is advising users that if the device starts up as normal, it is safe to continue to use. If the error occurs, it is recommended users use an alternative device or method. Niche Medical will be implementing a software upgrade as a permanent correction. This action has been closed-out on 16/02/2017.

Device

Tecotherm Neo (a heating/cooling system for use with infants)
  • Modelo / Serial
    Tecotherm Neo (a heating/cooling system for use with infants) Serial numbers: 2016/11/10 and belowARTG Number: 192036
  • Manufacturer
    Innervate Pty Ltd

Manufacturer

Innervate Pty Ltd