BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON

    MDR report key: 3944547 · Received May 9, 2014

    Report

    Report Number
    3009498591-2014-00019
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 8, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA INC.
    Product Code
    IYN
    PMA / PMN Number
    123622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS INTRODUCED WHEN WE FIXED US_00113852 (VC30A) / US_00114716 (VC25D); "MEASUREMENT VALUE CHANGES IN THE REPORT WHEN BASELINE IS CHANGED". WE REMOVED THE DEPENDENCE ON SOME PARAMETER UPDATES IN ORDER TO FIX THOSE ISSUES.

    Description of Event or Problem · 1

    WHILE SCANNING A CAROTID EXAM, USER PLACED A PULSED WAVEGATE WITHIN A STENOSIS IN THE EXTERNAL CAROTID ARTERY. SHE INCREASED THE PW PRF TO 13,021 (SLIGHTLY ABOVE 300 CM/S). THE AUTO-STAT MEASUREMENT CALIPER IS APPROPRIATELY PLACED (NEAR 300 CM/S) BUT THE DISPLAYED MEASUREMENT OF THE PEAK SYSTOLE VELOCITY IS 101.5 CM/S. THIS ISSUE IS REPRODUCTIBLE IN ALL EXAMS (EXCEPT CARDIAC) BY CHANGING MULTIHZ OR BASELINE OR SCALE WITH AUTO-STATS ENABLED. ON FREEZE, THE VELOCITY WILL DISPLAY FROM THE PREVIOUS SCALE. ALL VALUES IN THE MDA WILL BE INCORRECT, ANOTHER SCENARIO IS TO USE VELOCITY TOOL ON A LIVE IMAGE AND CHANGE MULTIHZ, THE VALUE DOES NT UPDATE IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281865 ACUSON DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1