Events

Retiro De Equipo (Recall) de Radiometer TCM5 transcutaneous blood gas 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-2016-RN-01416-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-11-02
  • 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-01416-1
  • 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 part of the specifications stated in the tcm5 instructions for use (ifu) for professionals for tc sensor 92 is incorrect.The current ifu state incorrectly under “combined effects of linearity and hysteresis” the following:- at 33 % co2: better than 3 mmhg or 0.40 kpathe correct statement is:- at 33 % co2: better than 5 mmhg or 0.67 kpa.The above correction is not considered to be of clinical significance.
  • Acción
    Radiometer is currently updating the Instructions for use and will distribute the updated version to customers when available. In the interim, users are notified of the update through the customer letter. This action has been closed-out on 23/06/2017. This action has been closed-out on 23/06/2017.

Device

Radiometer TCM5 transcutaneous blood gas monitor

Manufacturer

Radiometer Pacific Pty Ltd