BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 842322 · Received April 20, 2007

    Report

    Report Number
    MW1042636
    Event Type
    Malfunction
    Date Received
    April 20, 2007
    Date of Event
    February 28, 2007
    Report Date
    April 20, 2007
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BECAME AWARE OF EVENT 04/18/07. ABLATION CATHETER IN PT, GROUNDING DEVICE E7507 IN PLACE. WHEN ATTEMPTED TO BEGIN ABLATION, ALARM CAME UP STATING "TEST INDIFFERENT ELECTRODE." CALLED TECH SUPPORT AND WAS ADVISED TO TRY DIFFERENT INDIFFERENT ELECTRODE [E7506]. WAS ADVISED BY TECH SUPPORT THAT THEY HAVE HAD TO TELL OTHER END USERS TO USE DIFFERENT ELECTRODES AND PURCHASE A "SPLITTER" AS THIS MAY BE DUE TO PT PHYSIOLOGY. PROCEDURE ABORTED. DEVICE HAS NOT BEEN USED SINCE. CO CAME OUT AND EVALUATED DEVICE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER STOCKERT 70 ABLATION DEVICE GXD BIOSENSE WEBSTER ST 110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR