BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2180876 · Received July 21, 2011

    Report

    Report Number
    3030677-2011-00106
    Event Type
    Death
    Date Received
    July 21, 2011
    Report Date
    July 4, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ECG FROM INCIDENT REVIEWED. CONCLUSION: SHOCK WAS ADVISED THEN CANCELED DUE TO CHANGE IN ECG MORPHOLOGY. ISSUE IS BEING REPORTED DUE TO ASSOCIATED PATIENT OUTCOME.

    Description of Event or Problem · 1

    DEVICE DEPLOYED FOR USE. SUBJECT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS (HTST) M3860A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death