Events

Alerte De Sécurité sur Defibrillation Electrodes Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Cardiac Science.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-12-30
  • Date de publication de l'événement
    2015-12-30
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151230.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: cardiac science defibrillation electrodes used in powerheart g3 9300a, 9300e, 9300p, 9390a, and 9390e aeds the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning defibrillation electrodes (pn-9131-001) used in powerheart g3 9300a, 9300e, 9300p, 9390a, and 9390e automatic external defibrillators (aeds) manufactured by cardiac science. the affected lot number is 141125-02 and the expiration date of the electrodes is 12 june 2017. the manufacturer has determined powerheart g3 defibrillation electrodes (pn 9131-001) from lot number 141125-02 may exhibit higher than expected electrical impedance over time. if electrode impedance becomes too high, the powerheart g3 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 behaviour when the impedance limit is exceeded. in order to return the aed to its rescueready state, the high impedance electrodes require replacement. the manufacturer advises users to examine the electrodes currently installed in their aeds and in their inventory. also, users should replace affected electrodes even if they are in an aed and the status indicator is green. product replacement is on-going. for details, please refer to the mhra website:https://mhra.Filecamp.Com/public/file/2c5i-olg1li3l if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 december 2015.

Device

Defibrillation Electrodes Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cardiac Science Defibrillation Electrodes Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs
  • Manufacturer
    Cardiac Science

Manufacturer

Cardiac Science
  • Source
    DH