BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SC2000 ULTRASOUND SYSTEM

    MDR report key: 5607574 · Received July 1, 2015

    Report

    Report Number
    3009498591-2015-00165
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    April 12, 2015
    Report Date
    June 15, 2018
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA INC.
    Product Code
    IYN
    PMA / PMN Number
    K113179
    Removal / Correction Number
    300949859110072015009C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SIEMENS FOR EVALUATION; HOWEVER, THE SYSTEM LOG FILES WERE CAPTURED AND ANALYZED. DURING THE ANALYSIS, IT WAS FOUND THAT THE SOFTWARE WAS NOT STORING IMAGES DUE TO "CHECK-IN" FAILURES. WHEN SUBMITTING PATIENT INFORMATION IDENTICAL TO AN EXISTING PATIENT, EXCEPT FOR CASE DIFFERENCES IN THE PATIENT NAME, A SOFTWARE BUG WILL NOT ALLOW STORING OF IMAGES. THE IMAGE STORING ISSUE WAS RESOLVED IN SOFTWARE UPDATES VA35E (RELEASED 7 OCTOBER 2015), VB10D (RELEASED 10 JUNE 2016), AND VB20A (RELEASED 17 APRIL 2017). REFERENCE COMPLAINT # (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR OCCURRED DURING AN EXAM. THERE WAS NO PATIENT ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429789 ACUSON SC2000 ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1