BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3832680 · Received March 26, 2014

    Report

    Report Number
    3030677-2014-00916
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Report Date
    March 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY PENDING INVESTIGATION OF THE PT USE EVENT.

    Description of Event or Problem · 1

    DURING DEPLOYMENT A "NO SHOCK ADVISED" ASSESSMENT WAS GIVEN BY THE DEVICE. THE USER IS QUESTIONING THE "NO SHOCK ADVISED" DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176713 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3840A

    Patients

    Seq Age Sex Outcome Treatment
    1