BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR THERMOCOOL

    MDR report key: 2032231 · Received March 5, 2011

    Report

    Report Number
    2032231
    Event Type
    Malfunction
    Date Received
    March 5, 2011
    Date of Event
    December 29, 2010
    Report Date
    March 5, 2011
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NAVISTAR THERMOCOOL CATHETER WAS DISPLAYING UPSIDE DOWN. ALL OF THE CABLES AND CATHETERS WERE CONNECTED PROPERLY. WE CHANGED CATHETER AND THE PROBLEM WAS RESOLVED. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMOCOOL CATHETER, ABLATION, CARDIAC, RF LPB BIOSENSE WEBSTER * 15279565M

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR