BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 4081108 · Received September 8, 2014

    Report

    Report Number
    3030677-2014-02024
    Event Type
    Death
    Date Received
    September 8, 2014
    Date of Event
    June 29, 2014
    Report Date
    September 5, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION PENDING.

    Description of Event or Problem · 1

    THE USER IS QUESTIONING THE "NO SHOCK ADVISED" DECISION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547682 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3840A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death