Events

Retiro De Equipo (Recall) de Radiometer 905-873 Fixation Kit N20 (used with Radiometer TCM CombiM and Philips TC Gas10 for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures)

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-00636-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-15
  • 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-2015-RN-00636-1
  • 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
    The fixation kit consists of an adhesive which is the interface to the patient’s skin and on the other side, a plastic ring with a sensor retainer mechanism, which allows fastening a tc sensor 84 and tc sensor 54. in some cases, when the operator detaches the fixation ring from the paper liner, fractions of the paper liner’s surface coating sticks to the adhesive surface of the ring. the result is a varying degree of adhesiveness of the ring to the skin. if the ring and sensor fall off, the displaying data on the monitor will not be in range and thus identified by the medical professional. if the sensor is only in partial contact with the patient’s skin it may result in an incorrect measurement.
  • Acción
    Customers are advised to check inventory and stock in use for stock of the affected stock and discard them. Radiometer will provide free of charge replacement stock for stock that has been discarded. Users are advised to review customer results where affected stock was used and results were abnormal. This action has been closed-out on 15/08/2016.

Device

Radiometer 905-873 Fixation Kit N20 (used with Radiometer TCM CombiM and Philips TC Gas10 for con...
  • Modelo / Serial
    Radiometer 905-873 Fixation Kit N20 (used with Radiometer TCM CombiM and Philips TC Gas10 for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures)Lot Numbers: 407221, 407241, 407251, 408201, 409231, 410021, 410141, 410281, 411171, 411201, 411261, 412111, 412201, 501081, 501131, 501191, 501311, 502031, 502131, 502171, 502231, 502261, 503091, 503231, 503311, 504081, 504111, 505041, 505141.ARTG Number: 165940
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd