BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER

    MDR report key: 17774195 · Received September 19, 2023

    Report

    Report Number
    2184149-2023-00190
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    September 15, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05414734210713
    PMA / PMN Number
    K160187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 FREE OF PHYSICAL DAMAGE. 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 WERE 2 DIFFERENT MESSAGE TYPES, BUT BOTH WERE RELATED TO THE MICRO-PROCESSOR (¿) BOARD (PN: 100126432 SN: 005895); ¿INVALID ETHERNET ADAPTOR¿, AND ¿QBS (AGAINST ALL NOTED BOARDS)¿. 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 PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, TESTING WAS NOT ABLE TO DUPLICATE THE REPORTED EVENT. HOWEVER, THE REPORTED EVENT WAS ABLE TO BE CONFIRMED BY EVALUATION OF THE LOGS WHICH REVEALED THE ROOT CAUSE WAS DUE TO THE MICRO-PROCESSOR BOARD.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION PROCEDURE, THE AMPLIFIER DID NOT START PROPERLY AND THE PROCEDURE WAS CANCELLED. MULTIPLE RESTARTS DID NOT RESOLVE THE ISSUE WHICH RESULTED IN THE PROCEDURE BEING CANCELLED. THE PROCEDURE WILL BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447157 ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. EE3000 7519366 05414734210713

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown