Events

Rappel de Medtronic CryoConsole (A unit that applies a gaseous or liquid refrigerant to withdraw heat from target tissues or indirectly through contact with a cryogen-cooled probe.)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia 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-00853-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-04
  • 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-00853-1
  • 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
    Medtronic has identified a performance issue with a usb memory component that contains some of the system's software within a subset of cryoconsole models. testing indicated that the write speed of the usb memory component from a single supplier lot is slower than those compared to other lots. based on data from field complaints and internal testing, the difference in speed is known to cause the following issues:-1. during inflation of a cryoballon catheter, false detection of balloon deflation and display of system notice 22406 (the balloon is deflated);2. during a procedure, display of system notice 50008 (the system has detected a software error and stopped the injection).No injuries have been reported.
  • Action
    Users are advised that if a system notice appears, to carefully read and follow the instructions on the screen of the console. A Medtronic representative will also contact users to arrange a service of their CryoConsole system. This action has been closed-out on 18/08/2016.

Device

Medtronic CryoConsole (A unit that applies a gaseous or liquid refrigerant to withdraw heat from ...
  • Modèle / numéro de série
    Medtronic CryoConsole (A unit that applies a gaseous or liquid refrigerant to withdraw heat from target tissues or indirectly through contact with a cryogen-cooled probe.)Models 106A3, 106E2, 106A2-K ARTG Number: 164650
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA