Events

Retiro De Equipo (Recall) de TCM CombiM module (used with Radiometer Transcutaneous Monitors)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific 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-01200-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-21
  • 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-01200-1
  • 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
    Radiometer has recently become aware that tcm combi m modules with a serial number below 903-111r0174nxxx* may, on rare occasions, have an error that will cause the alarm sound to be higher than the pre-set maximum volume.If the alarm sound is higher than the pre-set volume then critically ill premature infants may experience a critical stress reaction if the tcm combi m monitor is placed close to the infant and the too high alarm is not silenced.
  • Acción
    Radiometer is advising users with devices in Newborn or NICU units to turn off the monitor and contact Radiometer if the error occurs. Radiometer will be replacing all units which are used in these areas. Radiometer is providing a warning label to be placed on all TCM4 units which are not used in the Newborn or NICU units, and to advise Radiometer if the error occurs. This action has been closed-out on 31/08/2016.

Device

TCM CombiM module (used with Radiometer Transcutaneous Monitors)
  • Modelo / Serial
    TCM CombiM module (used with Radiometer Transcutaneous Monitors)Product Code: 903-111Affected Serial Numbers: below 903-111R0174Nxxx ARTG Number:167226
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd