BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMASTER

    MDR report key: 21810867 · Received April 9, 2025

    Report

    Report Number
    8030229-2025-04856
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 13, 2025
    Report Date
    July 10, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    GWF
    UDI-DI
    00841983103629
    PMA / PMN Number
    K142624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE NEURO WORK BENCH WITH A MEE 2000A STIMULATOR FROZE DURING A PROCEDURE. THE CUSTOMER REPORTED THAT THE WIRELESS INTERNET DROPPED, WHICH CAUSED A VPN LOSS AND THIS MADE THE DEVICE(S) FREEZE. THE CUSTOMER REBOOTED THE DEVICE(S) AND AFTER THE REBOOT, THE NEURO WORK BENCH (NWB) INCLUDING MEE 2000A STIMULATOR SYSTEM WAS ABLE TO OPEN AND THEY WERE ABLE TO FINISH THE EXAM WITHOUT FURTHER ISSUES. NO PATIENT HARM WAS REPORTED. NOTE: THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). 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. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE MEE-2000A-LT: PC: MODEL#: A/DELL-5520 - LT, SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: 08/10/2023, UNIQUE DEVICE IDENTIFIER (UDI): NA, RETURNED TO MANUFACTURER: NA.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE EEG TECHNICIAN REPORTED THAT NEURO WORK BENCH (NWB), AS WELL AS THE MEE 2000A STIMULATOR FROZE DURING A PROCEDURE. THE WIRELESS CONNECTION DROPPED, WHICH CAUSED THE VPN TO DISCONNECT. AFTER REBOOTING THE EEG SYSTEM, THEY WERE ABLE TO OPEN AND FINISH THE EXAM WITHOUT ISSUE. NO PATIENT HARM WAS REPORTED. NOTE: THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). INVESTIGATION SUMMARY: THE SYSTEM LOGS WERE SENT IN FOR REVIEW. HOWEVER, NK WAS UNABLE TO CONFIRM THE REPORTED INCIDENT. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED, DUE TO LIMITED INFORMATION. THE ISSUE POSSIBLY STEMMED FROM THE FACILITY'S NETWORK ISSUES, DUE TO POSSIBLE WIRELESS AND/OR VPN CONNECTIVITY ISSUES AT THE OFFSITE LOCATION. AFTER THE SYSTEM WAS REBOOTED, THE ISSUE WAS RESOLVED. THE CUSTOMER WAS NOTIFIED THAT WE DID NOT FIND ANYTHING REMARKABLE, DURING THE REVIEW OF THE LOGS, THAT WOULD HELP US DETERMINE A CAUSE. SINCE CONTACT WAS LAST MADE WITH THE CUSTOMER, NO FURTHER ISSUES RELATED TO THIS INCIDENT HAVE BEEN REPORTED TO DATE. TRENDING FOR SIMILAR ISSUES AND DEVICES WILL CONTINUE TO BE MONITORED BY NK. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS CONNECTED TO AND SUPPORTS THE SOFTWARE NEEDED TO RUN THE MEE-2000A-LT: PC: MODEL #: A/DELL-5520 - LT. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 08/10/2023. RETURNED TO MANUFACTURER: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE NEURO WORK BENCH WITH A MEE 2000A STIMULATOR FROZE DURING A PROCEDURE. THE CUSTOMER REPORTED THAT THE WIRELESS INTERNET DROPPED, WHICH CAUSED A VPN LOSS AND THIS MADE THE DEVICE(S) FREEZE. THE CUSTOMER REBOOTED THE DEVICE(S) AND AFTER THE REBOOT, THE NEURO WORK BENCH (NWB) INCLUDING MEE 2000A STIMULATOR SYSTEM WAS ABLE TO OPEN AND THEY WERE ABLE TO FINISH THE EXAM WITHOUT FURTHER ISSUES. NO PATIENT HARM WAS REPORTED. NOTE: THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG).

    Description of Event or Problem · 0

    THE EEG TECHNICIAN REPORTED THAT NEURO WORK BENCH (NWB), AS WELL AS THE MEE 2000A STIMULATOR FROZE DURING A PROCEDURE. THE WIRELESS CONNECTION DROPPED, WHICH CAUSED THE VPN TO DISCONNECT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471587 NEUROMASTER NEURAL FUNCTION MEASURING SYSTEM GWF NIHON KOHDEN CORPORATION MEE-2000A-LT NA 00841983103629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown A/DELL-5520-LT COMPUTER| A/DELL-5520-LT COMPUTER