BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM

    MDR report key: 15790253 · Received November 14, 2022

    Report

    Report Number
    2184149-2022-00271
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQK
    UDI-DI
    05414734210713
    PMA / PMN Number
    K141050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: B5, H2 FURTHER INFORMATION RECEIVED FROM THE REPORTING PERSON CONFIRMED THIS EVENT IS A DUPLICATE. THIS EVENT WAS ALREADY REPORTED VIA PER-2022-0170728/MDR-2022-48466.

    Description of Event or Problem · 0

    THERE WAS SMOKE COMING FROM THE AMPLIFIER.

    Description of Event or Problem · 0

    FURTHER INFORMATION RECEIVED FROM THE REPORTING PERSON CONFIRMED THIS EVENT IS A DUPLICATE. THIS EVENT WAS ALREADY REPORTED VIA PER-2022-0170728/MDR-2022-48466.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416613 ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL 600073552 7653576 05414734210713

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown