BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SC2000

    MDR report key: 6156490 · Received December 8, 2016

    Report

    Report Number
    3009498591-2016-00651
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 8, 2016
    Report Date
    April 19, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K142628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    SERVICE PERSONNEL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE DEVICE AVAILABLE FOR EVALUATION (SEE D10), UPDATE THE FOLLOW-UP TYPE (SEE H2), UPDATE THE DEVICE EVALUATED BY MANUFACTURER (SEE H3), UPDATE THE EVENT PROBLEM AND EVALUATION CODES (SEE H6), AND PROVIDE THE INVESTIGATION RESULTS. INVESTIGATION: THE CAUSE FOR THE LOST STUDY WAS FROM A SOFTWARE BUG THAT THE PIM PROCESS COULD NOT HANDLE TWO SIMULTANEOUS CAPTURES IN SAME PROCESS DUE TO STATIC SHARED DATA THAT ARE USED IN IMAGESTORE, AND ALSO DUE TO SINGAPORE. THE FINAL SOLUTION FOR THIS PROBLEM WAS SOLVED IN A NEW SOFTWARE RELEASE FOR THE SC2000 ULTRASOUND SYSTEM. THE SOLUTION WAS TO MAKE THE PIM PROCESS THREAD SAFE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL EVENT INFORMATION (SEE SECTION B5), PROVIDE INITIAL REPORTER CONTACT INFORMATION (SEE SECTION E1), AND UPDATE DEVICE EVALUATED BY MANUFACTURER (SEE SECTION H3).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE SONOGRAPHER ATTEMPTED TO PERFORM A RENAL ARTERY EXAM; HOWEVER, THE SYSTEM IMMEDIATELY DISPLAYED A "FAILED TO CHECK THE STRUCTURE REPORT OBJECT" ERROR MESSAGE. THE SONOGRAPHER REPEATED THE EXAM WITH THE SAME EQUIPMENT BECAUSE THERE WAS A LOSS OF DATA WHICH WAS REPORTED TO BE UNRECOVERABLE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    STUDY WAS LOST. THE INVESTIGATION IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805945 ACUSON SC2000 DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown