Events

Retiro De Equipo (Recall) de Radiometer TCM5 FLEX/ BASIC Transcutaneous Monitor

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-2018-RN-00299-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-04-13
  • 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-2018-RN-00299-1
  • 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 previously informed users that they had received reports that instruments sensitive to electromagnetic interference may be affected by tcm5 measurements (tga ref: rc-2018-rn-00081-1 and rc-2017-rn-01327-1).Radiometer has released the revised version of the instructions for use which includes a separate paragraph in the introduction section under “electromagnetic interference”. this amendment is included from the tcm5 instructions for use, 996-436, version 201801f, pages 5 and 6. the updated ifu mirror the actions for users identified in rc-2018-rn-00081-1.
  • Acción
    Radiometer is advising users to discard previous revisions of the Instructions for Use and replace these with the new versions. Radiometer is working on a solution, which involves a hardware redesign of the TCM5 monitoring system, for this issue. Users will be contacted by their Radiometer representative when the final solution is available.

Device

Radiometer TCM5 FLEX/ BASIC Transcutaneous Monitor
  • Modelo / Serial
    Radiometer TCM5 FLEX/ BASIC Transcutaneous MonitorAll Serial NumbersARTG Number: 140333(Radiometer Pacific - Transcutaneous blood gas monitor)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd