BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ X DISPLAY WORKSTATION

    MDR report key: 20135769 · Received September 4, 2024

    Report

    Report Number
    2184149-2024-00151
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 26, 2024
    Report Date
    October 17, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067032171
    PMA / PMN Number
    K231415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENSITE X DISPLAY WORKSTATION (DWS) Z4 WAS RECEIVED FOR EVALUATION. THE DWS DEVICE ACCESSORIES WERE CONNECTED ALONG WITH POWER. POWER WAS APPLIED AND THE DWS PASSED THE POWER-ON-SELF-TEST (POST). THE HARDWARE TEST WAS ABLE TO LOAD SUCCESSFULLY, AND THE MEMORY TEST WAS PERFORMED, WHICH WAS SUCCESSFUL. 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. MEMORY 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 UNKNOWN.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, AN UNEXPECTED SHUTDOWN OCCURRED CAUSING A DELAY. AFTER 15 MINUTES OF MAPPING WITH THE ADVISOR HD GRID, THE SYSTEM FROZE AND IT WAS NOT POSSIBLE TO USE THE MOUSE OR KEYBOARD; NO ERROR MESSAGES WERE NOTED. AN ATTEMPT TO HIT CTRL+ALT+DEL DID NOT RESOLVE THE ISSUE. THE DWS ATTEMPTED TO REBOOT ITSELF WITHOUT SUCCESS. ATTEMPTS TO REBOOT THE DWS THREE TIMES WERE UNSUCCESSFUL. THE DWS WAS THEN FORCED TO SHUT DOWN BY PUSHING THE ON/OFF BUTTON FOR FIVE SECONDS, AND ALL CABLES CONNECTED TO THE DWS WERE DISCONNECTED AND RECONNECTED AND THE STUDY RESUMED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875215 ENSITE¿ X DISPLAY WORKSTATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. ENSITE-DWS-01 7824899 05415067032171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown