BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART

    MDR report key: 246656 · Received October 19, 1999

    Report

    Report Number
    51640-1999-00028
    Event Type
    Malfunction
    Date Received
    October 19, 1999
    Date of Event
    September 23, 1999
    Report Date
    September 29, 1999
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USER FACILITY TESTING ON 9/23/1999, THE UNIT TIMED OUT AND FAILED TO SHOCK AT 360 JOULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL A/S HS 3000 9704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA