Device Recall 9131 Defibrillator Electrodes

  • Modèle / numéro de série
    Lot No. 141125-02
  • Classification du dispositif
  • 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
  • 1 Event

Fabricant

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