BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ X DISPLAY WORKSTATION

    MDR report key: 23735272 · Received December 5, 2025

    Report

    Report Number
    2184149-2025-00206
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    December 1, 2025
    Report Date
    March 25, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQK
    UDI-DI
    05415067046710
    PMA / PMN Number
    K221213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6, H11. ONE ENSITE X DISPLAY WORKSTATION (DWS8) Z4 WAS RECEIVED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH THE MESSAGE LOGS, MEMORY TEST FAILING DURING DIAGNOSTICS, AND THE DWS UNRESPONSIVENESS. BASED ON THE INVESTIGATION, AND INFORMATION PROVIDED TO ABBOTT, THE ROOT CAUSE CANNOT BE DEFINITIVELY CONFIRMED; HOWEVER, THE FAILURE IS CONTAINED WITHIN THE SYSTEM.

    Description of Event or Problem · 0

    DURING THE RADIOFREQUENCY ATRIAL FIBRILLATION PROCEDURE IN VOXEL MODE, THERE WAS A DELAY DUE TO THE ENSITE DWS LAGGING AND CRASHING. WHILE MAPPING, THE ENSITE X DWS LAGGED AND CRASHED. THE DWS WAS RESTARTED THREE TIMES (EACH RESTART TOOK 15-20 MINUTES), BUT THE LAGGING ISSUE PERSISTED. THE DWS WAS REPLACED, AND THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105555 ENSITE¿ X DISPLAY WORKSTATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ABBOTT MEDICAL ENSITE-DWS-2.0.1 10707243 05415067046710

    Patients

    Seq Age Sex Outcome Treatment
    1