Events

Rappel de LIFEPAK 500 AUTOMATIC EXTERNAL DEFIBRILLATOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA 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
    47989
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-06-17
  • 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
    A field alert regarding apotential reliability issue is the result of a design characteristic of a sram (static random access memory) electronic component on the main printed circuit board assembly. this particular component can be susceptible to moisture ingress resulting in a potential malfunction. if this occurs the lifepak 500 device can fail to turn on. the purpose of this correction is to notify customers who own lifepak 500 aeds of this potential issue and provide guidance for device storage practices that may exacerbate the issue.

Device

LIFEPAK 500 AUTOMATIC EXTERNAL DEFIBRILLATOR
  • Modèle / numéro de série
    Model Catalog: 803499-00 (Lot serial: >100); Model Catalog: 3005400 (Lot serial: >100); Model Catalog: 3005332 (Lot serial: >100); Model Catalog: 3005335 (Lot serial: >100); Model Catalog: 3005338 (Lot serial: >100); Model Catalog: 805662 (Lot serial: >100); Model Catalog: 803499-09 (Lot serial: >100); Model Catalog: 3011790 (Lot serial: >100); Model Catalog: 500 (Lot serial: >100); Model Catalog: 3200390 (Lot serial: >100); Model Catalog: 3011520 (Lot serial: >100); Model Catalog: 3011111 (Lot serial: >100); Model Catalog: 3011020 (Lot serial: >100); Model Catalog: 3011019-000 (Lot serial: >100); Model Catalog: 3010779 (Lot serial: >100); Model Catalog: 3010698 (Lot serial: >100); Model Catalog: 3010697 (Lot serial: >100); Model Catalog: 3009767 (Lot serial: >100); Model Catalog: 3006535 (Lot serial: >100); Model Catalog: 3006007 (Lot serial: >100); Model Catalog: 3005578 (Lot serial: >100); Model Catalog: 3005389 (Lot serial: >100); Model Catalog: 3005381-002 (Lot serial: >100); Model Catalog: 3005381-001
  • Description du dispositif
    LIFEPAK 500 Automated External Defibrillator
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • 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