BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3072283 · Received April 18, 2013

    Report

    Report Number
    3030677-2013-00666
    Event Type
    Death
    Date Received
    April 18, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION PENDING. ISSUE IS BEING REPORTED PER PHILIPS REPORTING PRACTICE FOR ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DEVICE WAS DEPLOYED - SUBJECT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167596 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3840A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death