Events

Rappel de Device Recall VIGILANCE MONITOR

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Edwards Lifesciences Llc.

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
    35777
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1310-06
  • Date de mise en oeuvre de l'événement
    2006-06-21
  • Date de publication de l'événement
    2006-08-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-08-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46857
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    cardiac output monitor - Product Code DYG
  • Cause
    Edwards lifesciences vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the continuous cardiac output (cco) catheter without alerting the user to this situation. this can result in overheating and thermal damage to the cco catheter and serious patient injury.
  • Action
    Strategy to contact affected physicians accounts: Edwards will communicate to all accounts with affected monitors using distribution and sales records to identify those accounts. Letter dated 07/07/2006. In addition Edwards will analyze all CCO catheter sales and identify all accounts not on the monitor distribution list and include those accounts on the communication listing. Communication will be send via FedEx to the Risk Manager at each account with sufficient copies for the Heads of Departments of Surgery, Anesthesia, ICU, Nursing, Risk Management and Biomedical Engineering. Edwards will follow up by phone with each account that does not initiate contact per the Recall Letter. Edwards will make three attempts to contact the account by phone and complete the recall process.

Device

Device Recall VIGILANCE MONITOR
  • Modèle / numéro de série
    Lot Numbers: All devices serialized with software release 5.3 or earlier.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide
  • Description du dispositif
    EDWARDS VIGILANCE MONITORS || (FORMERLY BAXTER VIGILANCE MONITORS) || with software release 5.3 or earlier only. Patient monitor which measures cardiac output. || Models: VG, VGS, VGS1, VGS2, VG2, & IVM.
  • Manufacturer
    Edwards Lifesciences Llc

Manufacturer

Edwards Lifesciences Llc
  • Adresse du fabricant
    Edwards Lifesciences Llc, One Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA