Events

Rappel 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)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00636-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-15
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00636-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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