BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART ONSITE

    MDR report key: 2152995 · Received June 23, 2011

    Report

    Report Number
    3030677-2011-00092
    Event Type
    Death
    Date Received
    June 23, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY PENDING DEVICE EVALUATION, THE DEVICE HAS NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    AED DEPLOYED WHERE THE SUBJECT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART ONSITE MKJ PHILIPS MEDICAL SYSTEMS (HTST) M5066A B39069P-0919

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death