BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE MEDICAL SYSTEMS

    MDR report key: 663494 · Received January 9, 2005

    Report

    Report Number
    MW1037666
    Event Type
    Malfunction
    Date Received
    January 9, 2005
    Date of Event
    November 22, 2005
    Report Date
    December 1, 2005
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    DXK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SOFTWARE ON THE G.E. VIVID 7 ULTRASOUND DOES NOT ACCOMMODATE ENTRIES ON SAME INDIVIDUAL FOR MULTIPLE STUDIES. IMAGES AND DATA ARE EFFECTIVELY "LOST" OR UNABLE TO BE RETRIEVED ONCE 2ND STAGE OR EXAM IS COMPLETED. SOFTWARE DOES NOT ACCOUNT FOR ADDITIONAL STUDIES TO SAME PT ON DIFFERENT DAYS. IT WILL ERROR AND INDICATE THAT PT ALREADY EXISTS. IF A NEW EXAM IS STARTED, IT ASKS IF YOU WANT TO SAVE? WHEN "ALL" IS SELECTED, ORIGINAL IMAGES/DATA IS STILL THERE, BUT MOST RECENT STUDY IS NOT, WITH NO INDICATION OR ERROR NOTIFYING THE TECHNICIAN PERFORMING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE MEDICAL SYSTEMS VIVID 7 ECHO MACHINE DXK GE MEDICAL SYSTEMS VIVID 71930 BT02 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other