BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND IMAGING SYSTEM

    MDR report key: 42103 · Received October 9, 1996

    Report

    Report Number
    MW4001629
    Event Type
    Malfunction
    Date Received
    October 9, 1996
    Report Date
    August 29, 1996
    Manufacturer
    ACOUSTIC IMAGING TECHNOLOGIES, INC.
    Product Code
    LXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE "HADLOCK FORMULA MODE" DURING THE 12 TO 13 WEEK PERIOD (1ST TRIMESTER) TO DETERMINE FETAL CALCULATIONS, THE UNIT FAILS TO CALCULATE THE AVERAGE PROPERLY. INSTEAD OF APPROPRIATELY AVERAGING 13 WEEKS, THE SOFTWARE CAUSES AN AVERAGE OF 14 WEEKS TO BE DISPLAYED THUS GIVING THE PHYSICIAN INACCURATE DATA TO DIAGNOSE THE CORRECT AGE OF THE FETUS BASED ON ITS SIZE. THE UNIT WORKS FINE IN THE "AVERAGE MODE." SOFTWARE REVISIONS 5.51, 5.53, 5.6, AND 5.7 ARE AFFECTED AND WILL MISCALCULATE THE FETUS AGE WHEN USING THE "HADLOCK FORMULA MODE."RPTR NOTIFIED THE MFR AND ITS PARENT CO AND BOTH SAID THEY ARE AWARE OF THE SOFTWARE PROBLEMS. RPTR HAS DETERMINED THAT THE SOFTWARE IN FACT IS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOUND IMAGING SYSTEM DOPPLER ULTRASOUND FOR FETAL EVALUATION LXE ACOUSTIC IMAGING TECHNOLOGIES, INC. 5200E *

    Patients

    Seq Age Sex Outcome Treatment
    1 *