Events

Rappel de MEDI-TRACE CADENCE PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODES RADIOTRANSPARENT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COVIDIEN.

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
    95341
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2013-04-11
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer have received customer reports of arcing/sparking on the defibrillation electrode leadwire. covidien was also aware that the wire/connector subassembly supplier experienced equipment damage due to misalignment from installed tooling. this could r4sult in arcing sparking or thermal damage to the leadwire which could render the device incapable of delivering the appropriate energy or shock to the patient.

Device

MEDI-TRACE CADENCE PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODES RADIOTRANSPARENT
  • Modèle / numéro de série
    Model Catalog: 22550P (Lot serial: 301833X); Model Catalog: 22550P (Lot serial: 228651); Model Catalog: 22550P (Lot serial: 232146); Model Catalog: 22550P (Lot serial: 235646X); Model Catalog: 22550P (Lot serial: 303928X); Model Catalog: 22550R (Lot serial: 305320X); Model Catalog: 22550R (Lot serial: 304667X); Model Catalog: 22550R (Lot serial: 301844X); Model Catalog: 22550R (Lot serial: 300446X); Model Catalog: 22550R (Lot serial: 236641X); Model Catalog: 22550R (Lot serial: 226543x); Model Catalog: 22550R (Lot serial: 232805X); Model Catalog: 22550R (Lot serial: 232182X); Model Catalog: 22550R (Lot serial: 230814X); Model Catalog: 22550R (Lot serial: 230054X); Model Catalog: 22550R (Lot serial: 234245X)
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    MEDI-TRACE CADENCE PEDIATRIC RADIOTRANSPARENT DEFIBRILLATION ELECTRODES
  • Manufacturer
    COVIDIEN

Manufacturer

COVIDIEN
  • Adresse du fabricant
    SAINT-LAURENT
  • 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
    HC