Events

Rappel de Device Recall 9131 Defibrillator Electrodes

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 Corporation.

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
    72824
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0829-2016
  • Date de mise en oeuvre de l'événement
    2016-01-14
  • Date de publication de l'événement
    2016-03-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142304
  • 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
    Defibrillation electrodes may increase electrical impedance over time. if impedance becomes too high, the aed will fail the electrode self-test and it will not be rescue ready, the aed status indicator will be red and the aed will beep. this is normal behavior when the impedance limit is exceeded. the high impedance electrodes require replacement.
  • Action
    Cardiac Science sent an Urgent: Voluntary Medical Device Recall letter dated January 2016 starting on January 14, 2014. The letters were either addressed to Distributor or Customer. The letter described the problem and the product involved in the recall. Requested consignees to replace any electrodes from the lot 141125-02 and return them to Cardiac Science. Furthermore, it advised consignees to contact their customers or members of their facilities who need to be made aware by providing a copy of the notification letter and replacement electrodes if they were a distributor. For questions contact Cardiac Science Technical Support at 1-800-426-0337, option 1 in USA or +1-262-953-3500 OUS or via e-mail a9131cardiacscience.com. For questions regarding this recall call 800-426-0337.

Device

Device Recall 9131 Defibrillator Electrodes
  • Modèle / numéro de série
    Lot No. 141125-02
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US all states including PR except ND & RI. International Distribution to Argentina, Australia, Belgium, Bermuda, Canada, Chile, Colombia, Ecuador, France, Germany, Hong Kong, Iceland, Ireland , Israel, Lebanon, Malaysia, Malta, Norway, Oman, Philippines, Poland, Qatar, Romania, Russian Federation, Singapore, Slovenia, Sweden, Turkey, United Kingdom.
  • Description du dispositif
    9131-001 Defibrillation Electrodes, Lot No. 141125-02 || Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs || Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Adresse du fabricant
    Cardiac Science Corporation, N7 W22025 Johnson Dr, Waukesha WI 53186-1856
  • Société-mère du fabricant (2017)
    Cardiac Science Corporation
  • Source
    USFDA