BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2140921 · Received June 21, 2011

    Report

    Report Number
    3030677-2011-00090
    Event Type
    Death
    Date Received
    June 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY PENDING EVAL OF THE INCIDENT, THE CUSTOMER NOTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

    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 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS (HTST) M3860A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death