BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON

    MDR report key: 3944637 · Received May 5, 2014

    Report

    Report Number
    3009498591-2014-00014
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 10, 2014
    Report Date
    May 2, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA INC.
    Product Code
    IYN
    PMA / PMN Number
    123622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS A CODING ERROR INTRODUCED WITH A CHANGE TO SUPPORT BIPLANE IMAGING FOR THE 4.0 RELEASE (BEFORE THE 3.5 RELEASE WAS BRANCHED FROM THE 4.0 RELEASE). THE SCOPE OF A PARAMETER TO HANDLE CHANGING MULTIHZ IN DOPPLER WAS CHANGED WITHOUT A CORRESPONDING CHANGE IN THE CODE WHICH DETERMINES THAT THE STRIP SHOULD BE RESET. SO THE STRIP WAS NOT RESET AS IT SHOULD HAVE BEEN AND THE DOPPLER DATA FROM THE OLD FREQUENCY IS STILL DISPLAYED IN THE DOPPLER STRIP. THE LIKELIHOOD OF THE USER CHANGING THE DOPPLER FREQUENCY DURING SPECTRAL DOPPLER, THEN FREEZING WHILE THE OLD CINE STRIP DATA IS DISPLAYED (ON THE RIGHT-HAND SIDE) IS LOW. THIS WORKFLOW IS A RARE AND CONSIDERED A CORNER CASE.

    Description of Event or Problem · 1

    DURING IN-HOUSE TESTING, DOPPLER FREQUENCY CHANGE DOES NOT RESTART THE STRIP, BUT RATHER ALLOWS TWO DIFFERENT RESULTS BASED ON SCALE CHANGES. WHEN YOU CHANGE FREQUENCY DURING LIVE SPECTRAL DISPLAY, THE SPECTRAL STRIP SHOULD REFRESH, STARTING A NEW BLANK STRIP. INSTEAD THE OLD STRIP INFO IN RETAINED ON THE SCREEN. YOU SEE BOTH THE OLD DOPPLER DATA FROM THE PREVIOUS FREQUENCY DISPLAYED ON THE SAME STRIP AS THE NEW DOPPLER DATA WITH A BLACK LINE DIVIDING THEM. THE SCALE CHANGES AND IS CORRECT FOR THE NEW DOPPLER DATE. IN CINE, IF YOU MEASURE THE SAME THE DOPPLER DATA (E.G. PEAK VELOCITY) FROM BOTH THE OLD AND NEW DOPPLER FREQUENCIES, YOU WILL RECEIVE TWO DIFFERENT VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268058 ACUSON DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1