BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLTEK EP16

    MDR report key: 764047 · Received August 1, 2006

    Report

    Report Number
    9612330-2006-00001
    Event Type
    Malfunction
    Date Received
    August 1, 2006
    Date of Event
    June 22, 2006
    Report Date
    July 31, 2006
    Manufacturer
    EXCEL TECH. LTD.
    Product Code
    GWF
    PMA / PMN Number
    k992313
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NATURE OF THIS MALFUNCTION WAS DEEMED NOT TO BE SPECIFICALLY RELATED TO THE UNITS, BUT TO CHANGING THE SOFTWARE SETTINGS DURING AN ACTIVE PROCEDURE. THEREFORE, THE DEVICES WERE NOT REQUIRED TO BE SENT BACK TO THE MANUFACTURER FOR ANALYSIS. THE MANUFACTURER ATTEMPTED TO REPRODUCE THE MALFUNCTION BY USING SCENARIOS DESCRIBED BY THE INITIAL REPORTER. THE MALFUNCTION COULD NOT BE REPRODUCED IN LABORATORY ENVIRONMENTS, BUT KNOWING THAT CHECKING IMPEDANCE RESOLVED THE PROBLEM, IMPLIES THAT THE ELECTRONIC SWITCHES IN THE AMPLIFIER MODULE WERE NOT UPDATED PROPERLY TO REFLECT THE CHANGES TO THE TEST WHEN PERFORMED DURING AN ACTIVE STUDY. THIS IS THE FIRST TIME SUCH AN EVENT IS REPORTED TO THE MANUFACTURER. AS A PREVENTIVE MEASURE THE MANUFACTURER NOTIFIED ITS EP16 DEVICE USERS OF THIS POTENTIAL MALFUNCTION AND MORE IMPORTANLTY ABOUT THE IMPORTANCE TO PERFORM AN IMPEDANCE CHECK AFTER MODIFYING TEST SETTINGS DURING A PROCEDURE TO ENSURE THAT THE HARDWARE SWTICH SETTINGS ARE UPDATED TO THE SOFTWARE PROTOCOL.

    Description of Event or Problem · 1

    DURING TWO DIFFERENT ANTERIOR CERVICAL SURGERIES, THE EVOKED POTENTIAL DEVICE SOFTWARE PRESENTED FALSE POSITIVE CONSISTENT WITH SPINAL CORD INJURY THAT TRIGGERED INTERVENTION IN THE FORM OF THE SURGEON AND ATTENDING NEUROPHYSIOLOGY TECHNOLOGIST NEEDING TO PERFORM TROUBLESHOOTING ACTIVITIES, INCLUDING PERFORMING AN IMPEDANCE CHECK TO VERIFY THE CORRECT OPERATION OF THE DEVICE AND CONNECTION OF THE RECORDING ELECTRODES. THIS DEVICE MALFUNCTION OCCURRED IMMEDIATELY AFTER THE MEDICAL PRACTITIONER MODIFIED THE TEST SETTINGS OF THE EVOKED POTENTIAL DEVICE DURING THE ACTIVE PROCEDURE. AS PART OF THE TROUBLESHOOTING THE MEDICAL PRACTITIONER PERFORMED AN IMPEDANCE CHECK WHICH, BY RESETTING THE HARDWARE SWITCHES IN THE AMPLIFIER MODULE, ALLOWED THE SOFTWARE TO RETURN TO NORMAL. NO DATA WAS LOST. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XLTEK EP16 EVOKED POTENTIAL DIAGNOSTIC GWF EXCEL TECH. LTD. 10093 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN