BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISON

    MDR report key: 370658 · Received January 7, 2002

    Report

    Report Number
    MW1023776
    Event Type
    Malfunction
    Date Received
    January 7, 2002
    Report Date
    January 7, 2002
    Manufacturer
    MEDISON AMERICA, INC.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FETAL BIOMETRY MEASUREMENTS ARE AUTOMATICALLY STORED INTO WORKSHEET AND REPORT AND USED IN CALCULATIONS EVEN WITHOUT OPERATOR OF EQUIPMENT SELECTING THAT THE MEASUREMENT BE SAVED. THIS RESULTS IN ERRONEOUS CALCULATED DATA UNLESS THE OPERATOR EDITS THE DATA TO DELETE THE UNWANTED MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISON ULTRASOUND MACHINE IYN MEDISON AMERICA, INC. MEDISON V730 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *