BEUDAMED
    FDA Adverse Event Death Summary report: N

    FR2

    MDR report key: 1655090 · Received April 8, 2010

    Report

    Report Number
    3030677-2010-00059
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    January 8, 2010
    Report Date
    April 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    0003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FILES RELATED TO USE WERE EVALUATED, AED WAS NOT RETURNED. DEVICE INTERNAL MEMORY AND ECG FROM INCIDENT REVIEWED. CONCLUSION: REPORT IS BEING FILED BECAUSE IT CANNOT BE CONCLUSIVELY STATED THAT THE DEVICE DID NOT CONTRIBUTE TO THE ADVERSE EVENT. IT IS UNK WHY SHOCK BUTTON WAS NOT PRESSED WHEN USER WAS PROMPTED. SECOND SHOCK DECISION WAS REVERSED DUE TO CHANGE IN PRESENTING RHYTHM.

    Description of Event or Problem · 1

    DURING AED DEPLOYMENT. SHOCK WAS ADVISED AND RESPONDER DID NOT PRESS SHOCK BUTTON, SHOCK WAS ADVISED AND AED THEN ADVISED NO SHOCK. SHOCK WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR2 AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M3860A-ABJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Death