Events

Rappel de Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjunction with Automatic External Defibrillators) Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien 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-00803-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-08-31
  • 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-00803-1
  • 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
    This recall is being conducted due to a low-level potential for damage to the wire insulation which was identified during a review of our manufacturing process. no complaints for this issue have been reported from customers. the use of products with this condition may result in a potentially increased risk for either reduced or no patient therapy, arcing of current, sparking, and potential burns to the patient and/or clinician. no patient injuries have been reported regarding this damaged wire insulation issue.
  • Action
    Users are asked to immediately quarantine and discontinue use of the affected devices and to arrange return as per the instructions supplied. This action has been closed-out on 31/08/2016.

Device

Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjuncti...
  • Modèle / numéro de série
    Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjunction with Automatic External Defibrillators)Medi-Trace Cadence Adult Multi-Function Defibrillation ElectrodesItem Numbers: 22550PC, 22770PCLot Numbers: 517521X, 519835X, 516313X, 519124X, 513426X ARTG Number: 186124
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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