BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOKED RESPONSE ELECTRIC STIMULATOR

    MDR report key: 18673441 · Received February 8, 2024

    Report

    Report Number
    8030229-2024-04135
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 9, 2024
    Report Date
    April 17, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    GWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AN ERROR MESSAGE POPPED UP ON THE MEE SYSTEM DURING A PROCEDURE AND HAS BEEN AN INTERMITTENT ISSUE, CAUSING NEUROWORKBENCH (NWB) TO SPONTANEOUSLY RESTART. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED. ERROR MESSAGE: "AN UNEXPECTED ERROR OCCURRED DURING COMMUNICATION BETWEEN THE PC AND THE MAIN UNIT. THE MEASUREMENT PROGRAM WILL AUTOMATICALLY RESTART AND OPEN THE PREVIOUSLY ACQUIRED DATA. IF THIS MESSAGE APPEARS AGAIN AFTER RESTARTING THE PROGRAM, DO THE FOLLOWING: 1) CHECK THE LAN CABLE CONNECTION BETWEEN THE PC AND MAIN UNIT. 2) CHECK THAT THE NETWORK ADAPTER SETTING IS 100 MBPS FULL. 3) PRESS BOTH A/B BUTTONS ON THE OPERATION PANEL FOR 2 SECONDS TO RESET THE MAIN UNIT. <DESCRIPTION OF THE ERROR> AN ERROR OCCURRED WHILE SENDING SOME COMMANDS TO YOUR ACQUISITION BOX. FOR MORE DETAILS, SEE NEUROMASTER LOG 2052." INVESTIGATION SUMMARY: TECHNICAL SUPPORT (TS) EMAILED THE CUSTOMER ASKING TO SET UP A TIME AND DATE TO TROUBLESHOOT THE ISSUE. TS FOLLOWED UP WITH THE CUSTOMER ON 01/17/2024, 01/19/2024, 01/23/2024, 01/26/2024, 04/09/2024, AND 04/16/2024 BUT THE CUSTOMER WAS UNRESPONSIVE TO ALL ATTEMPTS MADE ASKING IF THEY STILL NEEDED ASSISTANCE OR IF THEIR ISSUE WAS RESOLVED. DUE TO LACK OF RESPONSE FROM THE CUSTOMER, NK WAS UNABLE TO DETERMINE A ROOT CAUSE. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTABLE TO CONNECTIVITY ISSUES SUCH AS CABLE CONNECTIVITY (LOOSE OR IMPROPERLY CONNECTED CABLES WHICH CAN LEAD TO SIGNAL LOSS AND INTERMITTENT CONNECTIVITY THAT MAY NOT TRANSMIT DATA EFFECTIVELY) OR INADEQUATE SETUP (SUCH AS INCORRECT IP ADDRESS OR INCORRECT SETTING FOR SPEED, DUPLEX, OR OTHER PARAMETERS NEEDED TO CONNECT THE PC TO THE MAIN UNIT). HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. DURING A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED ISSUE, WE FOUND ONLY ONE ISSUE THAT OCCURRED AT THIS FACILITY: TICKET # 200052 (REPORTED ON 01/09/2024). A REVIEW OF HISTORICAL DATA DOES NOT REVEAL A SIGNIFICANT TREND THAT WOULD CONTRIBUTE TO COMPONENT FAILURE THAT IS RELATED TO THE DESIGN OR MANUFACTURING OF THE DEVICE. WE WILL CONTINUE TO TREND FOR THIS DEVICE AND FACILITY FOR SIMILAR COMPLAINT ISSUES. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT #1 01/19/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 01/23/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 01/26/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WERE SOME ISSUES OF AN ERROR POPPING UP DURING A PROCEDURE. THE ERROR STATES "AN UNEXPECTED ERROR OCCURRED DURING COMMUNICATION BETWEEN THE PC AND THE MAIN UNIT. THE MEASUREMENT PROGRAM WILL AUTOMATICALLY RESTART AND OPEN THE PREVIOUSLY ACQUIRED DATA. IF THIS MESSAGE APPEARS AGAIN AFTER RESTARTING THE PROGRAM, DO THE FOLLOWING: 1) CHECK THE LAN CABLE CONNECTION BETWEEN THE PC AND MAIN UNIT 2) CHECK THAT THE NETWORK ADAPTER SETTING IS 100 MBPS FULL. 3) PRESS BOTH A/B BUTTONS ON THE OPERATION PANEL FOR 2 SECONDS TO RESET THE MAIN UNIT. <DESCRIPTION OF THE ERROR> AN ERROR OCCURRED WHILE SENDING SOME COMMANDS TO YOUR ACQUISITION BOX. FOR MORE DETAILS, NEUROMASTER LOG 2052." THIS ERROR MESSAGE HAS BEEN A SPORADIC ISSUE ON MACHINE 5 IN GR. NEUROWORKBENCH SPONTANEOUSLY RESTARTS IN THE MIDDLE OF MONITORING. IT CAN GO WEEKS WITHOUT AN INCIDENT, BUT IT HAPPENED TWICE (RECENTLY) WHILE MONITORING. THE TEST DOES RESUME WITHOUT ISSUE AFTER ABOUT 20 SECONDS. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. ATTEMPT #1 01/19/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 01/23/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 01/26/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AN ERROR MESSAGE POPPED UP ON THE MEE SYSTEM DURING A PROCEDURE AND HAS BEEN AN INTERMITTENT ISSUE, CAUSING NEUROWORKBENCH (NWB) TO SPONTANEOUSLY RESTART. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WERE SOME ISSUES OF AN ERROR POPPING UP DURING A PROCEDURE. THE ERROR STATES "AN UNEXPECTED ERROR OCCURRED DURING COMMUNICATION BETWEEN THE PC AND THE MAIN UNIT. THE MEASUREMENT PROGRAM WILL AUTOMATICALLY RESTART AND OPEN THE PREVIOUSLY ACQUIRED DATA. IF THIS MESSAGE APPEARS AGAIN AFTER RESTARTING THE PROGRAM, DO THE FOLLOWING: 1) CHECK THE LAN CABLE CONNECTION BETWEEN THE PC AND MAIN UNIT 2) CHECK THAT THE NETWORK ADAPTER SETTING IS 100 MBPS FULL. 3) PRESS BOTH A/B BUTTONS ON THE OPERATION PANEL FOR 2 SECONDS TO RESET THE MAIN UNIT. <DESCRIPTION OF THE ERROR> AN ERROR OCCURRED WHILE SENDING SOME COMMANDS TO YOUR ACQUISITION BOX. FOR MORE DETAILS, NEUROMASTER LOG 2052." THIS ERROR MESSAGE HAS BEEN A SPORADIC ISSUE ON MACHINE 5 IN GR. NEUROWORKBENCH SPONTANEOUSLY RESTARTS IN THE MIDDLE OF MONITORING. IT CAN GO WEEKS WITHOUT AN INCIDENT, BUT IT HAPPENED TWICE (RECENTLY) WHILE MONITORING. THE TEST DOES RESUME WITHOUT ISSUE AFTER ABOUT 20 SECONDS. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388164 EVOKED RESPONSE ELECTRIC STIMULATOR GWF NIHON KOHDEN CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown