Events

Rappel de Device Recall Sentry semi automatic external defibrillator (AED)

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 Defibtech, 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
    56729
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0077-2011
  • Date de mise en oeuvre de l'événement
    2010-08-27
  • Date de publication de l'événement
    2010-10-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94386
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    Data cards may include an incorrect format which may cause the aed to not function correctly.
  • Action
    Defibtech Initially notified customers by telephone on 8/27/10. Customers were notified of the product, the problem and the action to be taken. Customers were instructed to locate affected data cards and send them back to Defibtech for evaluation. If the data card was inserted into the AED, then the customer was instructed to check the AED software version. If the software version was at 2.005, the customer was instructed to keep the AED out of service until Defibtech could evaluate the returned data card. (Any other software version indicated that the device was not affected by a faulty data card). If the software version was any other version other than 2.005, then the customer was instructed to keep the AED in service unless the original service inquiry required it to remain out of service. If the data card was not inserted into the AED, then the customer was instructed to return the data card for evaluation. For any questions customers were to contact Customer Service at (866) 333-4241 from 8:30-5pm EST, M-F.

Device

Device Recall Sentry semi automatic external defibrillator (AED)
  • Modèle / numéro de série
    Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    USA - Nationwide Distribution and Puerto Rico
  • Description du dispositif
    DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). || The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
  • Manufacturer
    Defibtech, LLC

Manufacturer

Defibtech, LLC
  • Adresse du fabricant
    Defibtech, LLC, 741 Boston Post Rd Ste 201, Guilford CT 06437-2714
  • Source
    USFDA