Events

Rappel de Device Recall Powerheart AED G3

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 Cardiac Science, Inc..

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
    30704
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0399-05
  • Date de mise en oeuvre de l'événement
    2004-11-12
  • Date de publication de l'événement
    2005-01-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-06-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36660
  • 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 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 data.
  • Notes supplémentaires dans les données
    unknown device name - Product Code NPN
  • Cause
    Aeds may contain an electronic component that does not meet its full operating specifications. the aeds with this suspect electronic component may not functionn properly and may interfere with the aed's ability to delivery therapy. in the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
  • Action
    Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.

Device

Device Recall Powerheart AED G3
  • Modèle / numéro de série
    Model no. 9300A serial numbers: 361240 thru 361317, 362360 thru 362386, 362394, 362715 thru 362914, 364195 thru 364274, 364555 thru 364594, 364915 thru 365294.
  • Classification du dispositif
    Cardiovascular Devices
  • Distribution
    Throughout the United States, Canada and Europe.
  • Description du dispositif
    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.

Manufacturer

Cardiac Science, Inc.
  • Adresse du fabricant
    Cardiac Science, Inc., 5474 Feltl Rd, Minnetonka MN 55343-7982
  • Source
    USFDA