BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2854357 · Received November 28, 2012

    Report

    Report Number
    3030677-2012-01532
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Report Date
    November 6, 2012
    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). METHOD: ECG WAS REVIEWED. CONCLUSION: THE DEVICE PROPERLY ADVISED "NO SHOCK" BECAUSE, THE PRESENTING RHYTHM WAS NOT SHOCKABLE.

    Description of Event or Problem · 1

    DURING DEPLOYMENT THE USER QUESTIONED THE DEVICES "NO SHOCK" DECISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1