BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2850849 · Received November 20, 2012

    Report

    Report Number
    3030677-2012-01501
    Event Type
    Death
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 9, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CURRENTLY PENDING EVALUATION OF THE PT USE EVENT.

    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 M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death