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Neuromaster MEE-2000A-LTRecalls & reported problems

Nihon Kohden America, Inc. · MEE-2000 Neuromaster G1 Laptop system; performs Intraoperative and Evoked Potential studies · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841983103629), received between Jul 3, 2019 and Apr 9, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 3 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Connection Problem3
  • Failure to Deliver Energy2
  • Loose or Intermittent Connection2
  • Output Problem2
  • Complete Loss of Power1
  • Electrical /Electronic Property Problem1
  • Energy Output Problem1
  • Intermittent Shock/Stimulation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions7
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 9, 2025Output Problem; Output Problem

    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).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21810867 ↗
  • MalfunctionFeb 7, 2024Failure to Deliver Energy; Energy Output Problem; Output Problem; Failure to Deliver Energy; Energy Output Problem; Output Problem

    THE SURGICAL NURSE REPORTED THAT A PATIENT WAS UNDERGOING A SPINAL CORD STIMULATOR PLACEMENT PROCEDURE AND WHEN THE SURGICAL NURSE BEGAN MONITORING THE PATIENTS SOMATOSENSORY EVOKED POTENTIAL (SSEP'S) FOR DETECTION OF SPINAL CORD INJURY OR TETRALOGY OF FALLOUT (TOF) CARDIAC ANOMALY'S THERE WAS AN ERROR CODE THAT READ, "ELECTRICAL STIMULATOR TURNED OFF BECAUSE OF ERROR". RESTART THE ELECTRICAL STIMULATOR"?. THE SURGICAL NURSE PROCEEDED TO RESTART THE ELECTRICAL STIMULATOR AND STILL COULD NOT MONITOR THE PATIENT. THE SURGICAL NURSE REPORTED THAT THEY UNPLUGGED/PLUGGED THE STIM CABLE FROM THE STIM POD AS WELL AS THE MAIN UNIT. AFTER DOING THIS, THE DEVICE SHOWED ERROR CODES THAT SAID "YOU CANNOT RESTART THE AUTOMATIC TREND SEQUENCE, BECAUSE ELECTRIC A1-A4 ARE NOT CONNECTED. PLEASE CHECK THE STIMULATOR IS CONNECTED TO THE CONNECTOR ON THE RIGHT SIDE OF THE MAIN UNIT". THE SURGICAL NURSE NOTED THAT THE LIGHT ON THE STIM POD WAS NOT ON. THE SURGEON WAS AWARE THAT THE SURGICAL NURSE WAS HAVING TECHNICAL ISSUES DURING THE PROCEDURE. THE SURGICAL NURSE STATED THAT SINCE THE PROCEDURE WAS SO QUICK, THEY WERE NOT ABLE TO GET SPARE EQUIPMENT IN TIME, SO THEY WERE UNABLE TO MONITOR THE SOMATOSE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18663606 ↗
  • MalfunctionJan 17, 2024Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

    THE CUSTOMER REPORTED THAT THE STIMULATION POD WAS NOT STAYING CONNECTED DURING A PATIENT'S EXAMINATION AND WOULD NOT RECONNECT. NO PATIENT HARM WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18531524 ↗
  • MalfunctionJan 10, 2024Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MEE-2000A MAIN UNIT HAD A BAD AMPLIFIER CABLE. NO PATIENT HARM WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18485659 ↗
  • MalfunctionJan 6, 2024Connection Problem; Unexpected Shutdown; Connection Problem; Unexpected Shutdown

    THE BIOMEDICAL ENGINEER (BME) REPORTED HAVING ISSUES WITH THE PATCH CABLE CONNECTION BETWEEN THEIR LAPTOP AND THE NK MAIN UNIT. THEY RECEIVED AN ERROR MESSAGE STATING CONNECTION ERROR FAILURE WHEN STARTING THE MAIN UNIT. HOWEVER, IT HAPPENED TWO TIMES DURING A PROCEDURE, AND THEY HAD TO REBOOT AND HOLD THE CABLE IN TO GET IT TO START. THEY TRIED SWITCHING BETWEEN MULTIPLE CABLES, BUT THE ERROR STILL OCCURRED. NO PATIENT HARM WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18461132 ↗
  • MalfunctionJul 17, 2019Electrical /Electronic Property Problem; Failure to Deliver Energy; Intermittent Shock/Stimulation; Electrical /Electronic Property Problem; Failure to Deliver Energy; Intermittent Shock/Stimulation

    THE EEG TECH REPORTED THAT THE JB-201B STIMULATION POD WAS DELIVERING INTERMITTENT STIMULUS WHILE CONNECTED TO THE MEE-2000 DURING A PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 8800363 ↗
  • MalfunctionJul 3, 2019Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

    THE EEG TECH REPORTED THAT THE MEE SYSTEM SHUT DOWN AND RESTARTED DURING A 4EXT CERVICAL PROCEDURE. THE MEE-2000A IS AN IOM SYSTEM WHICH IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 8761452 ↗

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Sources and updates

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