BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3873690 · Received May 30, 2014

    Report

    Report Number
    3030677-2014-01345
    Event Type
    Death
    Date Received
    May 30, 2014
    Report Date
    May 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE EVAL PENDING THIS PT USE EVENT.

    Description of Event or Problem · 1

    THE USER ALLEGES THEY WERE UNABLE TO USE THE DEVICE DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319650 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3860A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death