BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSITE VELOCITY CARDIAC MAPPING SYSTEM

    MDR report key: 10899940 · Received November 25, 2020

    Report

    Report Number
    2184149-2020-00194
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 9, 2020
    Report Date
    November 24, 2020
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQK
    UDI-DI
    05414734210713
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER WAS RECEIVED INTO THE LAB FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED ALL INPUT AND OUTPUT CONNECTORS ARE FREE OF PHYSICAL DAMAGE AND ALL LABELING IS LEGIBLE AND CORRECTLY ORIENTED. POWER WAS APPLIED TO THE RETURNED AMPLIFIER WHICH SUCCESSFULLY COMPLETED THE POST (POWER ON SELF-TEST) AND THE SYSTEM STATUS LIGHT CHANGED TO GREEN. SYSTEM LOG FILES FORM THE REPORTED EVENT DATE OF (B)(6) 2020 WERE REVIEWED WHICH REVEALED RANDOM QBS ERRORS FOR THE CATHETER AMPLIFIER BOARDS IN SLOTS 4, 7 AND 9. A FULL FUNCTIONAL TEST WAS PERFORMED DURING THE EVALUATION PERIOD AND NO FAULTS, ERRORS OR CHANGES IN SYSTEM STATUS WERE OBSERVED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AS NO ABNORMALITIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    DURING AN AFL ABLATION PROCEDURE, AFTER USING THE AMPLIFIER FOR 1.5 HOURS, AN AMPLIFIER ERROR APPEARED ON THE ENSITE. WHILE TROUBLESHOOTING, IT WAS NOTICED THAT THE AMPLIFIER WAS FLASHING AMBER. AFTER POWER CYCLING THE AMPLIFIER TWICE, THE LIGHT WAS SOLID AMBER. THE PROCEDURE WAS ABORTED DUE TO THE REPORTED ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367423 ENSITE VELOCITY CARDIAC MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL EE3000 6359758 05414734210713

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other