BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYBEAT

    MDR report key: 234749 · Received July 20, 1999

    Report

    Report Number
    MW4002549
    Event Type
    Malfunction
    Date Received
    July 20, 1999
    Report Date
    July 15, 1999
    Manufacturer
    NICOLET VASCULAR, INC.
    Product Code
    LXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/8/99: CO HAS EXPERIENCED NO FIELD FAILURES WITH THIS RRODUCT SO THERE ISN'T ANY FAILURE ANALYSIS TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABYBEAT DOPPLER ULTRASOUND LXE NICOLET VASCULAR, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other