BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI RADIOFREQUENCY MODULE

    MDR report key: 3022708 · Received March 27, 2013

    Report

    Report Number
    1033422-2013-00015
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 25, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD WAS NOT COMPLETED AS THE RETURNED DEVICE SHOWED NO FAILURE. KIMBERLY-CLARK RECEIVED THE DEVICE FOR EVALUATION. THE CABLE PERFORMED AS EXPECTED IN ALL TESTS FOR CONTINUITY, CAPACITANCE AND FUNCTIONAL TESTING WITH PMG(GENERATOR) AND NO FAILURE WAS DETECTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, 'EVERYTHING WORKS GREAT WHEN IN STIM AND MOTOR MODES, BUT WHEN SWITCHED TO THE LESION MODE THE MACHINE NOTES A TEMPERATURE WARNING. THE PHYSICIAN HAD TO ABORT A PROCEDURE BECAUSE AFTER LESION ONE LEVEL, THE MACHINE KEPT INDICATING A TEMPERATURE PROBLEM. IT DIDN'T MATTER WHICH PROBE WAS USED OR WHICH PORT IT WAS PLUGGED INTO (A,B,C, OR D).' KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125657 MULTI RADIOFREQUENCY MODULE RADIO FREQUENCY CABLE GXI KIMBERLY-CLARK HEALTH CARE CE2313-R415

    Patients

    Seq Age Sex Outcome Treatment
    1