BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE X EP SYSTEM DISPLAY WORKSTATION

    MDR report key: 15580540 · Received October 11, 2022

    Report

    Report Number
    2184149-2022-00247
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    October 6, 2022
    Report Date
    December 8, 2022
    Manufacturer
    ST. JUDE MEDICAL
    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

    CORRECTED INFORMATION: B5, D1, D3, D4, D9 THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE COMMUNICATION ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. NO CAPA IS REQUIRED; THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONFIRMED TO BE A MANUFACTURING, DESIGN, OR QUALITY SYSTEM RELATED OCCURRENCE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED COMMUNICATION ISSUE AND SUBSEQUENT DELAY REMAIN UNKNOWN.

    Description of Event or Problem · 0

    DURING THE ATRIAL TACHYCARDIA PROCEDURE, THE AMPLIFIER AND DWS WERE NOT COMMUNICATING WHICH CAUSED A DELAY IN THE PROCEDURE. THE ENSITE X WAS SET UP AND THE AMPLIFIER AND THE DWS WERE SWITCHED ON. EVERYTHING WAS WORKING, BUT THE SYSTEM WARNED THAT THE FIELD FRAME WAS NOT CONNECTED. THE AMPLIFIER WAS SWITCHED OFF, THE FIELD FRAME WAS CONNECTED, AND THE AMPLIFIER WAS SWITCHED ON AGAIN. THE AMPLIFIER AND DWS WERE REBOOTED A FEW TIMES, EVERYTHING ON THE FRONT OF THE ENSITE X WAS UNPLUGGED, AND THE OPTIC FIBER WAS REPLACED WITH NO RESOLUTION. THE GREEN LED WAS STILL FLASHING AFTER A SUCCESSFUL AUTO-TEST. THE ENSITE X WAS SWITCHED OFF, THE POWER CORD WAS EXCHANGED, THE MAGNETIC FIELD FRAME WAS UNPLUGGED, AND THE DWS WAS TURNED OFF. THE DWS WAS THEN RESTARTED, AND THE AMPLIFIER WAS TURNED ON. HOWEVER, THE GREEN LIGHT WAS STILL BLINKING. EVERYTHING WAS THEN UNPLUGGED AND SWITCHED OFF. THE THREE SMALL DONGLES THAT CONNECT THE TACTISYS TO THE ENSITE X, AMPERE TO ENSITE X, AND DWS TO ENSITE X WERE REMOVED. THE ENSITE X AND DWS WERE THEN RESTARTED, WHICH RESOLVED THE ISSUE. THE CONNECTION WAS SUCCESSFUL, AND THE GREEN LIGHT WAS NO LONGER BLINKING. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    DURING THE ATRIAL TACHYCARDIA PROCEDURE, THE AMPLIFIER AND DWS WERE NOT COMMUNICATING WHICH CAUSED A DELAY IN THE PROCEDURE. THE ENSITE X WAS SET UP AND THE AMPLIFIER AND THE DWS WERE SWITCHED ON. EVERYTHING WAS WORKING, BUT THE SYSTEM WARNED THAT THE FIELD FRAME WAS NOT CONNECTED. THE AMPLIFIER WAS SWITCHED OFF, THE FIELD FRAME WAS CONNECTED, AND THE AMPLIFIER WAS SWITCHED ON AGAIN. THE AMPLIFIER AND DWS WERE REBOOTED A FEW TIMES, EVERYTHING ON THE FRONT OF THE ENSITE X WAS UNPLUGGED, AND THE OPTIC FIBER WAS REPLACED WITH NO RESOLUTION. THE GREEN LED WAS STILL FLASHING AFTER A SUCCESSFUL AUTO-TEST. THE ENSITE X WAS SWITCHED OFF, THE POWER CORD WAS EXCHANGED, THE MAGNETIC FIELD FRAME WAS UNPLUGGED, AND THE DWS WAS TURNED OFF. THE DWS WAS THEN RESTARTED, AND THE AMPLIFIER WAS TURNED ON. HOWEVER, THE GREEN LIGHT WAS STILL BLINKING. EVERYTHING WAS THEN UNPLUGGED AND SWITCHED OFF. THE THREE SMALL DONGLES THAT CONNECT THE TACTISYS TO THE ENSITE X, AMPERE TO ENSITE X, AND DWS TO ENSITE X WERE REMOVED. THE ENSITE X AND DWS WERE THEN RESTARTED, WHICH RESOLVED THE ISSUE. THE CONNECTION WAS SUCCESSFUL, AND THE GREEN LIGHT WAS NO LONGER BLINKING. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THE FIBER OPTIC CABLE WAS FOUND TO BE BENT AND WAS EXCHANGED, BUT THE ISSUE PERSISTED. FOLLOWING FURTHER TROUBLESHOOTING THE ISSUE WAS ISOLATED TO THE DISPLAY WORKSTATION AS EXCHANGING THE DEVICE RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390741 ENSITE X EP SYSTEM DISPLAY WORKSTATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL ENSITE-DWS-01 7896749 05415067032171

    Patients

    Seq Age Sex Outcome Treatment
    1 Female