BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ X DISPLAY WORKSTATION

    MDR report key: 20145683 · Received September 5, 2024

    Report

    Report Number
    2184149-2024-00154
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 3, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067032171
    PMA / PMN Number
    K202066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENSITE X DISPLAY WORKSTATION (DWS) Z4 WAS RECEIVED FOR EVALUATION. THE DWS PASSED THE POWER-ON-SELF-TEST, THE OPERATING SYSTEM AND APPLICATION MAIN LOG-IN SCREEN SUCCESSFULLY LOADED WITH NO ERRORS. THE KEYBOARD AND MOUSE FUNCTIONS WORKED AS EXPECTED. HARDWARE DIAGNOSTICS REVEALED THE MEMORY AND HARD DRIVE TESTS WERE SUCCESSFUL. FURTHER TESTING WAS NOT ABLE TO BE DONE AS THE LOG-IN INFORMATION WAS NOT RETURNED. HARDWARE EVALUATION TESTING WAS SUCCESSFUL. BASED ON THE INVESTIGATION AND INFORMATION PROVIDED TO ABBOTT, THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED, AND THE ROOT CAUSE REMAINS UNDETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED.

    Description of Event or Problem · 0

    DURING THE ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THERE WERE ISSUES WITH THE ENSITE X SYSTEM. AT TIMES IT WAS NOT POSSIBLE TO SELECT ANYTHING USING LEFT CLICK, AND THE DWS WAS RESTARTED TO RESOLVE THE ISSUE. AT ONE MOMENT, GEOMETRY WAS UNABLE TO BE EDITED DUE TO A LACK OF FUNCTIONALITY OF THE LEFT CLICK, AND SHORT CUTS WERE NOT FUNCTIONING. THE AMPERE GENERATOR AND DWS DISCONNECTED WHEN ABLATING. RESTARTING THE DWS AGAIN RESOLVED THE ISSUE. THE DWS HAD ISSUES EACH TIME SOMETHING WAS DISCONNECTED OR CONNECTED, OR WHEN VALIDATION OR DISTORTION WAS PERFORMED. THE DWS WAS RESTARTED AT LEAST 4 TIMES THROUGHOUT THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139794 ENSITE¿ X DISPLAY WORKSTATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. ENSITE-DWS-01 7914835 05415067032171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown