BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRX DEFIB EU-ONLY FRENCH SE (WB), 4TH ED

    MDR report key: 13446545 · Received February 3, 2022

    Report

    Report Number
    3030677-2022-00707
    Event Type
    Death
    Date Received
    February 3, 2022
    Date of Event
    January 20, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838080768
    PMA / PMN Number
    P180028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE USER IS REPORTING THE DEVICE DID NOT ADVISE A SHOCK FOR WHAT APPEARED TO BE A SHOCKABLE RHYTHM. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451250 FRX DEFIB EU-ONLY FRENCH SE (WB), 4TH ED AED MKJ PHILIPS NORTH AMERICA LLC 861304 00884838080768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death