Events

Rappel de Device Recall ReviveR AEDDefibtech Sentry

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
    37394
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0581-2007
  • Date de mise en oeuvre de l'événement
    2007-02-17
  • Date de publication de l'événement
    2007-03-08
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50474
  • 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
    Semi-Automatic External Defibrilator - Product Code MKJ
  • Cause
    Device malfunction-the self-test software may allow a self-test to clear a previously detected low battery condition. if this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
  • Action
    Defibtech LLC initiated notification to customers/distributors on 2/17/07 by email. Hard copy letters followed on 2/22/07 with acknowledgement card. Users provided with instructions for 'Immediate Recommendations' until the unit''s software is upgraded. Distributors, their customers, and direct accounts instructed to locate affected units and upgrade these units in the field. Distributors, their customers, and direct accounts shall return to Defibtech documentation confirming unit software upgrade was completed..Press was issued by the firm on March 6, 2007

Device

Device Recall ReviveR AEDDefibtech Sentry
  • Modèle / numéro de série
    Software versions earlier than version 2.002
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.
  • Description du dispositif
    Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)
  • Manufacturer
    Defibtech, LLC

Manufacturer

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