BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 6047237 · Received October 21, 2016

    Report

    Report Number
    1226348-2016-10742
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 30, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE MICROSENSOR WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED, AS THE BAR CODE LABEL WAS MISSING FROM THE DEVICE AND NO SERIAL OR LOT NUMBER INFORMATION WAS PROVIDED. EVALUATION OF THE RETURNED DEVICE FOUND NO VISIBLE DAMAGE TO THE SENSOR. THE CATHETER MATERIAL WAS SEVERELY KINKED 40.6 CM FROM THE CONNECTOR. THE DEVICE PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. REFER TO MDR 1226348-2016-10741 FOR INFORMATION REGARDING THE SECOND DEVICE INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE SURGEON WAS CHANGED SETTING ZERO. AFTER THAT THE PATIENT MOVED TO ICU. WHEN THE SURGEON STARTED MONITORING OF INTRACRANIAL PRESSURE SHOWED MINUS 45MMHG ON THE DISPLAY. THE SURGEON THINKS THAT PROPER VALUE IS 2-3 MMHG. WHAT¿S CAUSED THIS PROBLEM? NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698606 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 82-6637