BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART FRX

    MDR report key: 2707826 · Received August 15, 2012

    Report

    Report Number
    3030677-2012-00945
    Event Type
    Death
    Date Received
    August 15, 2012
    Date of Event
    July 31, 2012
    Report Date
    August 14, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS/DUP
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ECG FROM DEPLOYMENT WAS REVIEWED. DEVICE ANALYSIS RECOMMENDED SHOCK, AND SHOCK WAS DELIVERED. A TOTAL OF 3 SHOCK ADVISORIES WERE ISSUED AND SHOCKS WERE DELIVERED DURING THIS DEPLOYMENT. DEVICE PASSED INTERNAL SELF DIAGNOSTIC CHECKS CONDUCTED AFTER DEPLOYMENT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DEVICE WAS DEPLOYED IN AN ATTEMPT TO RESUSCITATE A DROWNING VICTIM. DEVICE ADVISED AND DELIVERED 3 SHOCKS, HOWEVER, VICTIM WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART FRX MKJ PHILIPS MEDICAL SYSTEMS/DUP 861304

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Death