BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND SYSTEM

    MDR report key: 6168378 · Received December 12, 2016

    Report

    Report Number
    3009498591-2016-00653
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 15, 2016
    Report Date
    February 1, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K152369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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), AND UPDATE THE EVENT PROBLEM AND EVALUATION CODES (SEE H6), AND PROVIDE THE INVESTIGATION RESULTS. ROOT CAUSE FOR THE ISSUE WAS THAT THE LARGE ROI (REGION OF INTEREST) WITH ASSC 5 WOULD FORCE SOME PARAMETERS OUT OF RANGE, RESULTING IN THE US_IMG_29 ERROR MESSAGE. THE FINAL SOLUTION WAS ADDRESSED IN SOFTWARE RELEASE VE10A.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE GENDER OF THE PATIENT (SEE SECTION A3), PROVIDE ADDITIONAL EVENT INFORMATION (SEE SECTION B5), UPDATE THE BRAND NAME OF THE DEVICE (SEE SECTION D1), CORRECT THE INITIAL REPORTER INFORMATION (SEE SECTIONS E1,E2,E3), UPDATE DEVICE EVALUATED BY MANUFACTURER (SEE SECTION H3), CORRECT THE DEVICE AND RESULT CODES (SEE SECTION H6), AND PROVIDE ADDITIONAL MANUFACTURER NARRATIVE. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SIEMENS FOR EVALUATION; THEREFORE, THE INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED AND THE CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT WHEN THE USER TURNED THE POWER ON FOR THE COLOR DOPPLER DURING A TRANSVAGINAL ULTRASOUND STUDY, THE SYSTEM DISPLAYED A US_IMG_29 ERROR MESSAGE. THE PATIENT WAS MOVED TO A DIFFERENT ROOM USING ANOTHER EQUIPMENT TO COMPLETE THE STUDY, THUS CAUSING A HALF AN HOUR DELAY IN PATIENT CARE. IT WAS NOT NECESSARY TO REPEAT THE STUDY BECAUSE THERE WAS NO LOSS OF DATA. THERE WAS NO PATIENT OR USER 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

    THE CUSTOMER WAS PERFORMING A TRANSVAGINAL STUDY, DURING WHICH THE SYSTEM DISPLAYED AN ERROR MESSAGE. THE PATIENT WAS THEN MOVED TO A DIFFERENT ROOM TO COMPLETE THE STUDY CAUSING A DELAY. THE INVESTIGATION IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817940 ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. S2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown