BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED

    MDR report key: 834752 · Received April 3, 2007

    Report

    Report Number
    3023750-2007-00069
    Event Type
    Death
    Date Received
    April 3, 2007
    Date of Event
    February 26, 2007
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K002232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE DEVICE HAS BEGUN, BUT IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT ADVISED SHOCK, BUT THEN IT SHUT DOWN AND THE "DO NOT USE" SYMBOL APPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ MKJ WELCH ALLYN PROTOCOL, INC. AED20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death