BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE X  EP SYSTEM DISPLAY WORKSTATION

    MDR report key: 14207952 · Received April 26, 2022

    Report

    Report Number
    2184149-2022-00110
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 25, 2022
    Report Date
    July 29, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K202066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, H4.

    Additional Manufacturer Narrative · 0

    ONE ENSITE X DISPLAY WORKSTATION (DWS) Z4 WAS RECEIVED FOR EVALUATION. POWER WAS APPLIED AND THE DWS PASSED THE POWER-ON-SELF-TEST (POST). THE DWS LOADED THE OPERATING SYSTEM SUCCESSFULLY THEN ENSITE APPLICATION MAIN LOG-IN SCREEN LOADED SUCCESSFULLY WITH NO ERRORS. HARDWARE DIAGNOSTICS REVEALED BOTH THE MEMORY AND THE HARD DRIVE TESTS WERE SUCCESSFUL. THE ENSITE X DWS WAS CONNECTED TO AN ENSITE X AMPLIFIER AND COMMUNICATIONS WAS ESTABLISHED SOLID GREEN ¿READY¿ STATUS. THE SMALL FORM-FACTOR PLUGGABLE (SFP) TRANSCEIVER WAS THEN INSPECTED; ALL INDICATOR LIGHTS WERE OBSERVED ACTIVE. THE AMPLIFIER AND THE DWS WAS LEFT ON AND COMMUNICATING OVERNIGHT, AT NO TIME DURING THE EVALUATION WAS THERE ANY COMMUNICATION LOSS. THE REPORTED EVENT WAS NOT ABLE TO BE DUPLICATED. 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.

    Description of Event or Problem · 0

    DURING AN ATRIAL FLUTTER PROCEDURE, A COMMUNICATION ERROR OCCURRED BETWEEN THE DWS AND THE GENERATOR AFTER 15~20 MINUTES AND THE GENERATOR WAS FLASHING GREEN. THE DWS AND GENERATOR WERE POWER CYCLED, THE CABLE WAS REMOVED AND THE OPTICAL CABLE WAS EXCHANGED WITH NO RESOLUTION. BOTH THE LAMPS (ORANGE, GREEN) ON THE BACK OF THE DWS AND THE SIDE OF THE OPTICAL CABLE CONNECTION PORT WERE OFF. THE DWS AND THE GENERATOR WERE POWER CYCLED THREE TIMES AND THE GENERATOR TURNED FLASHING IN GREEN. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540652 ENSITE X  EP SYSTEM DISPLAY WORKSTATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. ENSITE-DWS-01 7946621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown