Events

Field Safety Notices about Defibrillation Electrodes

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Cardiac Science.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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

Defibrillation Electrodes

Manufacturer

Cardiac Science