BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART FRX

    MDR report key: 2153025 · Received June 28, 2011

    Report

    Report Number
    3030677-2011-00096
    Event Type
    Death
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 10, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE ECG WAS REVIEWED FOR THIS INCIDENT. CONCLUSION: SUBJECT'S RHYTHM WAS A BORDERLINE SHOCKABLE RHYTHM, THE DEVICE OPERATED ACCORDINGLY AND REVERSED A SHOCKABLE RHYTHM ONCE THE RHYTHM BECAME NON-SHOCKABLE DUE TO ECG MORPHOLOGY.

    Description of Event or Problem · 1

    DURING AED DEPLOYMENT, THE SUBJECT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART FRX MKJ PHILIPS MEDICAL SYSTEMS (HTST) 861304

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death