BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH & NEPHEW

    MDR report key: 4253537 · Received November 12, 2014

    Report

    Report Number
    MW5039046
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 1, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN UNIT PLUGGED IN IT CAUSED LOUD ERROR SOUND "3" FLASHED ON SCREEN - DEVICE NOT WORKING. SECOND DEVICE TRIED (ON DIFFERENT BOX) SAME RESULT. A THIRD PROBE TRIED ON SECOND BOX WORKED WITHOUT EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729515 SMITH & NEPHEW WHIRLWIND PROBE 50 GEI SMITH & NEPHEW, INC. 1075703
    729516 SMITH & NEPHEW WHIRLWIND PROBE 50 GEI SMITH & NEWPHEW INC. 1071453

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR