Avis De Sécurité sur Defibrillation Electrodes

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Cardiac Science.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Cardiac science has determined powerheart g3 defibrillation electrodes (pn 9131-001) from lot no. 141125-02 may exhibit higher than expected electrical impedance over time. if electrode impedance becomes too high, your powerheart g3 automatic external defibrillator (aed) will fail the electrode self-test performed by the aed and it will not be rescue ready®. specifically, if the aed fails the electrode self-test, the status indicator on the aed will be red and the aed will beep. this is standard behavior when the impedance limit is exceeded. in order to return the aed to its rescueready state, the high impedance electrodes require replacement. .

Device

Manufacturer