BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER CS EZ STEER

    MDR report key: 1934807 · Received December 13, 2010

    Report

    Report Number
    1934807
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTRODES 5 AND 6 WERE NOT FUNCTIONAL ON DISPLAY MONITOR. ELECTRODES 5, 6, 7, 8 HAD ARTIFACT ON MONITOR. THE SIGNALS WERE NOT ACCURATE. THE CATHETER WAS REPLACED AND THE PROBLEM RESOLVED. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEBSTER CS EZ STEER CATHETER, MAPPING, CARDIAC DRF BIOSENSE WEBSTER NA 15190507

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR