BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE X DWS V5.0.1

    MDR report key: 24576501 · Received March 11, 2026

    Report

    Report Number
    2184149-2026-00065
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQK
    UDI-DI
    05415067053510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT STATED THAT "THE DWS LAUNCHED INTEGRATED ICE, AND THE DWS WOULD FREEZE WHEN ICE IMAGE CONTOURS WERE SELECTED AND SAVED." THE CASE STUDY AND LOG FILES WERE REVIEWED. ATTEMPTS TO REPLICATE THE FREEZE WERE ATTEMPTED. THE ISSUE WAS NOT REPLICATED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED DUE TO THE EXACT BEHAVIOR NOT BEING REPLICABLE.

    Description of Event or Problem · 0

    DURING A RADIOFREQUENCY ABLATION VENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A PROCEDURAL DELAY. THE CATHETER DISPLAYED CORRECTLY, BUT WHEN ATTEMPTING TO SAVE AN ICE IMAGE USING ENSITE ECHO, THE ENSITE DWS FROZE. THE VIEWMATE MULTI, ENSITE DWS, AND ENSITE X AMPLIFIER WERE RESTARTED MULTIPLE TIMES WITH NO RESOLUTION. THE DWS AND CATHETER WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28453 ENSITE X DWS V5.0.1 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ABBOTT MEDICAL ENSITE-DWS-05 11192869 05415067053510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown VIEWFLEX¿ X ICE CATHETER SENSOR ENABLED¿.