BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON

    MDR report key: 5607661 · Received July 1, 2015

    Report

    Report Number
    3009498591-2015-00022
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    March 25, 2015
    Report Date
    January 27, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA INC.
    Product Code
    IYN
    PMA / PMN Number
    072786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEER EVALUATED THE SYSTEM, AND FOUND THE PATIENT NAME, PATIENT ID, PATIENT DATE OF BIRTH, AND THE PATIENT GENDER MATCH, THE SYSTEM WORKS AS EXPECTED. THEREFORE THE ROOT CAUSE IS THE PATIENT'S NAME HAVING A DIFFERENCE IN UPPER/LOWER CASE FROM THE ORIGINAL GENERATION OF THIS PATIENT,AND THE SOFTWARE IS NOT CORRECTLY ACCOUNTING FOR THIS DIFFERENCE. THE SYSTEM SEES THIS AS TWO PATIENTS WITH 3 OF 4 IDENTIFIERS MATCHING, AND DOES NOT ALLOW THE CAPTURE OF CLIPS/IMAGES. THERE IS A LIMITATION IN THE SC2000 CODE WHICH DOES NOT CHECK FOR THE CASE OF THE PATIENT NAME DETERMINING UNIQUENESS. THE RESULT WHEN FOLLOWING THE WORKFLOW STEPS DESCRIBED ABOVE IS THAT THERE ARE TWO PATIENTS WITH IDENTICAL PATIENT INFORMATION EXCEPT FOR THE CASE OF THE NAME. DUE TO THE SC2000 SOFTWARE LIMITATION, THE CAPTURE SOFTWARE CANNOT PUT THE NEW IMAGES/CLIPS INTO A STUDY WITH THE "NEW" NAME WHEN ALL OTHER IDENTIFIERS MATCH. THE SYSTEM TREATS UPPER/LOWER CASE DIFFERENCES AS IF IT IS A DIFFERENT PATIENT NAME. WITH 3.5B AND NEWER VERSIONS, A DIALOG BOX WAS IMPLEMENTED TO INSTRUCT USERS THAT THEY MATCH 3 OF 4 IDENTIFIERS AND AT THE END OF THE STUDY. THE SUBSEQUENT FALLOUT OF HOW THE USER RESPONDS TO THE POP-UP MESSAGES RESULTING FROM ISSUE A END UP CAUSING THE REGISTRATION TO FAIL. A SAFETY UPDATE (US24/15/S) WAS ISSUED TO RESOLVE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    WHEN PT NAME, PT ID, PT DATE OF BIRTH, AND THE PT GENDER MATCH, THE SYSTEM WORKS AS EXPECTED. IN THE CASE OF THE PT'S NAME HAVING A DIFFERENCE IN UPPER/LOWER CASE FROM THE ORIGINAL GENERATION OF THIS PT, THE SW IS NOT CORRECTLY ACCOUNTING FOR THIS DIFFERENCE. THE SYSTEM SEEMS THIS AS TWO PTS WITH 3 OR 4 IDENTIFIERS MATCHING, AND DOES NOT ALLOW THE CAPTURE OF CLIPS/IMAGES. THIS WILL BE RESOLVED VIA SOFTWARE RELEASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PT FILE WAS NOT SAVED CORRECTLY WHEN ENDING THE EXAM. THE INVESTIGATION REVEALED THAT IMAGES ARE NOT ACQUIRED DURING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429743 ACUSON DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1