BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XELERIS WORKSTATION

    MDR report key: 521887 · Received February 5, 2004

    Report

    Report Number
    9613299-2004-00002
    Event Type
    Malfunction
    Date Received
    February 5, 2004
    Date of Event
    December 1, 2003
    Report Date
    February 5, 2004
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    GEMS RECEIVED A REPORT CONCERNING MISMATCH BETWEEN PT NAME AND PT DATA. CASE OCCURRED WHILE APPLYING XTRNA APPLICATION ON XELERIS PROCESSING AND REVIEWING WORKSTATION. XTRNA APPLICATION IS AN APPLICATION FOR CARDIAC CALCULATIONS. THIS APPLICATION CALCULATES CARDIAC EJECTION FRACTION (EF) AMONG OTHER PARAMETERS. IN CASE OF PROTOCOL FAILURE IN EF CALCULATIONS DUE TO EXTREMELY LOW COUNTS IN ONE OF THE VENTRICLES AN ERROR MESSAGE APPEARS ON SCREEN BUT THE OPERATOR CAN RESTORE THE APPLICATION FOR THE NEXT PT. THE SCREEN THEN CARRIES THE CORRECT NEW PT NAME BUT THE DATA THAT APPEARS ON THE SCREEN CARRIES THE DATA OF THE PREVIOUS PT. THE SAME EF CALCULATION CAN BE CARRIED OUT WITH SIMILAR APPLICATION (ER ANALYSIS) WITH NO ERRORS. PROBLEM WAS FOUND DURING TRAINING SESSION WHILE APPLICATION SPECIALIST DEMONSTRATES XTRNA APPLICATION TO LOCAL CUSTOMER. UPON REQUEST OF CUSTOMER TO CHECK LOCAL DATABASE OF PTS WITH LOW EF VALUES, THE APPLICATION FAILS AND DEMONSTRATES THE ABOVE-MENTIONED PROBLEM. NO INJURY OCCURRED OR ANY OTHER ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XELERIS WORKSTATION NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 2372897 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *