BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER

    MDR report key: 24465374 · Received February 26, 2026

    Report

    Report Number
    2184149-2026-00050
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    December 29, 2025
    Report Date
    April 9, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQK
    UDI-DI
    05414734210713
    PMA / PMN Number
    K201181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENSITE VELOCITY¿ AMPLIFIER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE FRONT PANEL PORTS, CHASSIS, AND LABELS WERE SHOW SIGNS OF WEAR CONSISTENT WITH USE OVER TIME. POWER WAS APPLIED TO THE AMPLIFIER AND THE AMPLIFIER PASSED POWER-ON-SELF-TEST (POST). THE AMPLIFIER WENT STATUS READY ¿GREEN¿ AND COMMUNICATED WITH THE TEST ENSITE COMPUTER. EVALUATION OF THE BOARD STATUS SHOWED ALL BOARDS STATUS ARE GREEN INDICATING PASSING RESULTS. EVALUATION OF THE LOGS REVEALED DISCOVERED NOTABLE SYMPTOMS. THERE WAS A SINGLE INCIDENCE OF A COMMUNICATION SYMPTOM (CON/SON) (B(6) 2024, WITH SLOT 6 (CATHETER AMPLIFIER BOARD). THERE WAS MULTIPLE LOGS WITH MULTIPLE QBS¿S ASSIGNED TO THE CURRENT SOURCE BOARD. IT WAS NOTED THAT THERE WAS ALSO TIMING ISSUES RELATED TO THE SLOT 2 PREVIOUSLY. AS THE CURRENT SOURCE BOARD IS THE PRIMARY SOURCE FOR GROUND AND IMPEDANCE MAPPING, WHICH HAD COMMUNICATION TIMING ISSUES, IT COULD NOT BE ELIMINATED FROM THE DISTORTION OF THE REPORTED SYMPTOM, AND SO WAS RETAINED AND CONFIRMED AS A CAUSE. THE REPORTED EVENT WAS RETAINED AS A CONFIRMATION BY INSPECTION OF THE LOGS. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE REPORTED EVENT WAS NOT ABLE TO BE REPRODUCED, HOWEVER THE ROOT CAUSE WAS RETAINED AS A COMMUNICATION TIMING SYMPTOM OF THE CURRENT SOURCE BOARD. THE BATCH RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED.

    Description of Event or Problem · 0

    DURING A RF ATRIAL FIBRILLATION PROCEDURE, WHEN USING THE ENSITE VELOCITY AMPLIFIER, DISTORTION OF THE ABLATION CATHETER WAS OBSERVED RESULTING IN CANCELLATION OF THE PROCEDURE. TRANSSEPTAL PUNCTURE AND MAPPING OF THE LEFT ATRIUM HAD BEEN COMPLETED. TROUBLESHOOTING INCLUDED REPLACING THE AMPERE GENERATOR, GENCONNECT CABLE, AND GROUNDING PATCH, BUT THE ISSUE PERSISTED. IT WAS NOTED THAT THE GROUNDING PATCH WAS ABOVE THE SYSTEM REFERENCE, AND THE AMPERE GENERATOR WAS PLUGGED INTO THE SAME CIRCUIT FOR POWER. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531901 ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ABBOTT MEDICAL 600079116 10052678 05414734210713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown