Neuromaster G1 DC-200BRecalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 04931921118054), received between Jun 8, 2017 and Feb 10, 2026 — classified as 73 malfunctions.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (16 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Application Program Problem

  THE BIOMEDICAL ENGINEER (BME) THE CUSTOMER REPORTED THAT THE IS CRASHING AFTER RECORDING FOR 2.5 HOURS CAUSING HER TO RESTART HER EXAM. SHE MENTIONED THIS STARTED ABOUT A WEEK AGO AND AFTER SEARCHING THE EVENT VIEWER TECH SUPPORT FOUND AN ENTRY FOR AN UPDATE TO THEIR ANTIVIRUS. TECH SUPPORT ASKED THEM TO REACH OUT TO THEIR LOCAL IT FOR HELP REMOVING THE UPDATE SINCE BEFORE THEN PC WORKED WITHOUT ISSUES. THEY SHOULD TRY THAT AND SEE IF THAT RESOLVES THE ISSUE. THE CUSTOMER HAS BEEN UNRESPONSIVE TO CORRESPONDENCES WHETHER REMOVING THE UPDATE RESOLVED THEIR ISSUE. NO PATIENT HARM WAS REPORTED. 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 24309907 ↗
• MalfunctionApr 9, 2025Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem

  THE CUSTOMER REPORTED THAT THE MAIN UNIT DEVICE FAILED STEMMING DURING PROCEDURE. THE CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE STATING "ERROR A3 AND A4 STIMULATORS WERE NOT CONNECTED" DURING A PROCEDURE. THE CUSTOMER REPORTED THAT EVERYTHING WAS CONNECTED AND THE PROGRAM WAS RESTARTED, BUT THE ISSUE PERSISTED. THE CUSTOMER SWAPPED THE STIM CABLE AND BOXES BUT THE ISSUE STILL PERSISTED. THE CUSTOMER REMOVED AND REPLACED THE MAIN UNIT FOR A WORKING UNIT AND CONTINUED THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OCCURRED. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21810680 ↗
• MalfunctionMar 5, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE HAVING A SIMILAR ISSUE AS IN COMPLAINT (B)(4). THEY WERE IN THE MIDDLE OF OBTAINING BASELINE DATA WHEN THE MEE-2000A SHUTDOWN. ALL THE SIGNALS WENT BLACK OUT OF NOWHERE, AND THEN THERE WAS AN ERROR MESSAGE FOR A MAIN UNIT FAILURE. THEN THE PROGRAM WOULD NOT CLOSE, AND IT KEPT STIMULATING SSEPS WHEN TRYING TO CLOSE IT. THEY ARE ABLE TO REBOOT IT, AND IT SEEMS TO RESOLVE THE ISSUE. HOWEVER, THE ISSUE REOCCURS. THEY DO NOT KNOW IF IT WAS IN PATIENT USE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531882 ↗
• MalfunctionMar 5, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE HAVING A SIMILAR ISSUE AS IN COMPLAINT (B)(4). THEY WERE IN THE MIDDLE OF OBTAINING BASELINE DATA WHEN THE MEE-2000A SHUTDOWN. ALL THE SIGNALS WENT BLACK OUT OF NOWHERE, AND THEN THERE WAS AN ERROR MESSAGE FOR A MAIN UNIT FAILURE. THEN THE PROGRAM WOULD NOT CLOSE, AND IT KEPT STIMULATING SSEPS WHEN TRYING TO CLOSE IT. THEY ARE ABLE TO REBOOT IT, AND IT SEEMS TO RESOLVE THE ISSUE. HOWEVER, THE ISSUE REOCCURS. THEY DO NOT KNOW IF IT WAS IN PATIENT USE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531679 ↗
• MalfunctionMar 5, 2025Electrical /Electronic Property Problem; Unintended Application Program Shut Down; Electrical /Electronic Property Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN DURING A PROCEDURE. THE CUSTOMER REPORTED THERE WAS AN ERROR MESSAGE FOR A MAIN UNIT FAILURE AND THEN THE PROGRAM WOULD NOT CLOSE AND IT KEPT STIMULATING SSEPS WHEN THEY WERE TRYING TO CLOSE IT. THERE WAS NO PATIENT HARM. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529724 ↗
• MalfunctionMar 5, 2025Electrical /Electronic Property Problem; Unintended Application Program Shut Down; Electrical /Electronic Property Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN DURING A PROCEDURE. THE CUSTOMER REPORTED THERE WAS AN ERROR MESSAGE FOR A MAIN UNIT FAILURE AND THEN THE PROGRAM WOULD NOT CLOSE AND IT KEPT STIMULATING SSEPS WHEN THEY WERE TRYING TO CLOSE IT. THERE WAS NO PATIENT HARM. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529348 ↗
• MalfunctionMar 5, 2025Electrical /Electronic Property Problem; Unintended Application Program Shut Down; Electrical /Electronic Property Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT WHILE IN THE MIDDLE OF OBTAINING THE BASELINE DATA, THE EEG TECH STATED THAT ALL SIGNALS WENT BLACK AND SHE GOT A "MAIN UNIT FAILURE" ERROR MESSAGE, THEN THE SYSTEM SHUT DOWN. WHEN TRYING TO CLOSE THE PROGRAM, IT KEPT STIMULATING SSEPS. NO PATIENT HARM WAS REPORTED. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528981 ↗
• MalfunctionMar 5, 2025Electrical /Electronic Property Problem; Unintended Application Program Shut Down; Electrical /Electronic Property Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN DURING A PROCEDURE. THE CUSTOMER REPORTED THERE WAS AN ERROR MESSAGE FOR A MAIN UNIT FAILURE AND THEN THE PROGRAM WOULD NOT CLOSE AND IT KEPT STIMULATING SSEPS WHEN THEY WERE TRYING TO CLOSE IT. THERE WAS NO PATIENT HARM. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528890 ↗
• MalfunctionMar 5, 2025Electrical /Electronic Property Problem; Unintended Application Program Shut Down; Electrical /Electronic Property Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN DURING A PROCEDURE. THE CUSTOMER REPORTED THERE WAS AN ERROR MESSAGE FOR A MAIN UNIT FAILURE AND THEN THE PROGRAM WOULD NOT CLOSE AND IT KEPT STIMULATING SSEPS WHEN THEY WERE TRYING TO CLOSE IT. THERE WAS NO PATIENT HARM. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528669 ↗
• MalfunctionMar 5, 2025Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Unintended Application Program Shut Down; Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN DURING A PROCEDURE. THE CUSTOMER REPORTED THERE WAS AN ERROR MESSAGE FOR A MAIN UNIT FAILURE AND THEN THE PROGRAM WOULD NOT CLOSE AND IT KEPT STIMULATING SSEPS WHEN THEY WERE TRYING TO CLOSE IT. THERE WAS NO PATIENT HARM. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528217 ↗
• MalfunctionJul 16, 2024Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT AFTER LAUNCHING THE PROGRAM, THEY HAD TROUBLE INCREASING THE STIMULATION INTENSITY ON THIS INTRAOPERATIVE MONITORING (IOM) SYSTEM USING THE DIAL; IT DID NOT RESPOND. NO REPORTS OF PATIENT HARM.THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752271 ↗
• MalfunctionMar 4, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THE POWER FAILURE ON THE NEUROMASTER G1, CAUSING THE MAIN UNIT TO CONSTANTLY POWER DOWN WHEN STARTING AN EXAM. IT WAS REPLICATED MULTIPLE TIMES AND FOLLOWS THE DC-200BA MAIN UNIT. THE MEE SYSTEM MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832907 ↗
• MalfunctionFeb 22, 2024Failure to Deliver Energy; Output Problem; Failure to Deliver Energy; Output Problem

  THE CUSTOMER REPORTED THAT AN ELECTRIC A STIM BOX # (B)(6) DID NOT WORK ON A CASE. THE CUSTOMER CHANGED BOTH THE CABLE AND STIM BOX FROM ANOTHER MACHINE AND THE SYSTEM WORKED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760088 ↗
• MalfunctionFeb 22, 2024Failure to Deliver Energy; Output Problem; Failure to Deliver Energy; Output Problem

  THE CUSTOMER REPORTED THAT AN ELECTRIC A STIM BOX #352 DID NOT WORK ON A CASE. THE CUSTOMER CHANGED BOTH THE CABLE AND STIM BOX FROM ANOTHER MACHINE AND THE SYSTEM WORKED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759522 ↗
• MalfunctionFeb 21, 2024Energy Output Problem; Output Problem; Energy Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE (B)(6) MAIN UNIT HAD A TCMEP STIM ISSUE. THEY CHANGED OUT THE (B)(6) TCMEP STIM CABLE, BUT THE ISSUE PERSISTED. THEY SWAPPED OUT THE (B)(6) MAIN UNIT, AND THIS FIXED THE STIM ISSUE. THE MAIN UNIT IS THE DEVICE THAT FAILED OF THE MEE SYSTEM WHICH MEASURES AND DISPLAYS ELECTRIC, AUDITORY, AND VISUAL EVOKED POTENTIALS (EP), ELECTROENCEPHALOGRAMS (EEG), AND ELECTROMYOGRAPHS (EMG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753781 ↗
• MalfunctionFeb 16, 2024Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE STIMULATOR HAD FAILED DURING A PROCEDURE. THE CUSTOMER SWAPPED THE STIMULATOR OUT WITH A DIFFERENT STIMULATOR FROM ANOTHER MACHINE AND THAT SYSTEM WORKED. AT THE END OF THE CASE, THE CUSTOMER TRIED ANOTHER PROTOCOL WITH THE STIMULATOR USED DURING THE PROCEDURE THAT FAILED AND AGAIN IT DID NOT WORK. NO PATIENT HARM WAS REPORTED. THE CUSTOMER IS RETURNING THE STIMULATOR JS-201B TO NIHON KOHDEN AND RECEIVED A REPLACEMENT. 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 18722445 ↗
• MalfunctionJan 2, 2024Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT EMG WAS TRIGGERED, INDICATING THAT THE REPORTED CURRENT IS NOT ACCURATE UNDER 2MA AND DIFFERS FROM THE ACTUAL CURRENT PROVIDED. IT IS UNKNOWN WHETHER THE UNIT WAS IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432381 ↗
• MalfunctionAug 18, 2023Failure to Deliver Energy; Energy Output Problem; Output Problem; Failure to Deliver Energy; Energy Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MEE-2000A WOULD NOT CONNECT TO THE STIMULATOR DURING THE EXAM. AFTER TROUBLESHOOTING, TECH SUPPORT (TS) DISCOVERED THE MAIN UNIT FOR THE SYSTEM WAS THE ISSUE. THE MEE-2000A NEURAL FUNCTION MEASURING SYSTEM IS INTENDED TO MONITOR, RECORD, AND DISPLAY THE BIOELECTRIC SIGNALS PRODUCED BY SENSORY AND MOTOR PATHWAYS; AND THE SYSTEM MEASURES AND DISPLAYS ELECTRIC/ AUDITORY/VISUAL EVOKED POTENTIAL (EP), ELECTROENCEPHALOGRAPHY (EEG), AND ELECTROMYOGRAPHY (EMG), SKIN TEMPERATURE OF DISTAL PORTION OF EXTREMITIES, SPO2, AND ETCO2. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573265 ↗
• MalfunctionAug 2, 2023Unable to Obtain Readings; Defective Component; Output Problem; Unable to Obtain Readings; Defective Component; Output Problem

  THE CUSTOMER REPORTED THAT THE STIM CABLE WAS BROKEN. ACCORDING TO THE CUSTOMER, THERE WAS NO SIGNAL OUT FOR TWO CHANNELS, JUST A FLAT LINE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Numbness; Stenosis

  MAUDE report 17444528 ↗
• MalfunctionJul 12, 2023Loss of Power; Power Problem; Loss of Power; Power Problem

  THE CUSTOMER REPORTED THAT THIS ELECTRICAL BOX STOPPED OUTPUTTING POWER DURING A PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17307934 ↗
• MalfunctionAug 12, 2022Output Problem; Output Problem

  THE SYSTEMS ADMINISTRATOR FOR CLINICAL NEUROPHYSIOLOGY REPORTED THAT THEY HAD EXPERIENCED ISSUES WITH THIS ACQUISITION DURING A CASE. THE TECH REPORTED THAT DURING STIMULATION THEY HAD RECEIVED MULTIPLE ERRORS. THESE ERRORS HAVE NOT BEEN SPECIFIED. THEN THEY REPORTED THAT A AND B BUTTON STOPPED RESPONDING, AND THEY WERE UNABLE TO STOP THE STIMULATION. SHE THEN SELECTED THE AUTO SEQUENCE FEATURE ONCE THE STIMULATION STOPPED, AND SHE TRIED TO TEST THE MANUAL STIMULATION. IT WAS AT THIS TIME THEY RECEIVED AN ERROR MESSAGE STATING "CANNOT STIMULATE DUE TO INTERNAL ERROR IN WAVEFORM PROCESSOR. STOP STIMULATION IMMEDIATELY." THEY REBOOTED THE UNIT BUT WITH NO RESOLUTION. THE MEE-2000A NEURAL FUNCTION MEASURING SYSTEM IS INTENDED TO MONITOR, RECORD, AND DISPLAY THE BIOELECTRIC SIGNALS PRODUCED BY SENSORY AND MOTOR PATHWAYS; AND THE SYSTEM MEASURES AND DISPLAYS ELECTRIC/ AUDITORY/VISUAL EVOKED POTENTIAL (EP), ELECTROENCEPHALOGRAPHY (EEG), AND ELECTROMYOGRAPHY (EMG), SKIN TEMPERATURE OF DISTAL PORTION OF EXTREMITIES, SPO2, AND ETCO2. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222293 ↗
• MalfunctionJun 30, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THEY WERE RUNNING SOME DUMMY PATIENT TESTING WITH THE DC-200BA MAIN UNIT FOR THE MEE-2000A SYSTEM. THEY SYSTEM CRASHED. THE MEE-2000A NEURAL FUNCTION MEASURING SYSTEM IS INTENDED TO MONITOR, RECORD, AND DISPLAY THE BIOELECTRIC SIGNALS PRODUCED BY SENSORY AND MOTOR PATHWAYS; AND THE SYSTEM MEASURES AND DISPLAYS ELECTRIC/ AUDITORY/VISUAL EVOKED POTENTIAL (EP), ELECTROENCEPHALOGRAPHY (EEG), AND ELECTROMYOGRAPHY (EMG), SKIN TEMPERATURE OF DISTAL PORTION OF EXTREMITIES, SPO2, AND ETCO2. NOT IN PATIENT USE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875453 ↗
• MalfunctionJun 17, 2022Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE MEE-2000A IS DISCONNECTING DURING EXAM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14738523 ↗
• MalfunctionMay 20, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE UNIT IS CONTINUING TO HAVE POWER ISSUES WITH THE DC-200B MAIN UNIT FOR THE MEE-2000A. THIS ISSUE IS INTERMITTENT, AND THE MAIN UNIT WILL SHUT DOWN RANDOMLY. THE ISSUE IS NOT RESOLVED AND IS STILL OCCURRING. THIS IS THE THIRD OCCURRENCE, AND THE OTHER 2 HAVE BEEN REPORTED IN 300290922 AND 300288051. THE MEE-2000A NEURAL FUNCTION MEASURING SYSTEM IS INTENDED TO MONITOR, RECORD, AND DISPLAY THE BIOELECTRIC SIGNALS PRODUCED BY SENSORY AND MOTOR PATHWAYS; AND THE SYSTEM MEASURES AND DISPLAYS ELECTRIC/ AUDITORY/VISUAL EVOKED POTENTIAL (EP), ELECTROENCEPHALOGRAPHY (EEG), AND ELECTROMYOGRAPHY (EMG), SKIN TEMPERATURE OF DISTAL PORTION OF EXTREMITIES, SPO2, AND ETCO2. THE UNIT WAS NOT IN PATIENT USE WHEN THE 3RD OCCURRENCE HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459294 ↗
• MalfunctionApr 14, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE INTER-OPERATIVE MONITORING TECHNICIAN REPORTED THAT THE MEE-2000 SHUTDOWN DURING ACQUISITION. THEY WERE PERFORMING A TEST WHEN THE DC-200B MAIN UNIT'S LEDS WENT ON AND THE PROGRAM STOPPED WITH THERE WAS AN ERROR MESSAGE WHICH WAS THE SAME AS IN ANOTHER COMPLAINT (B)(4) WHICH WAS ALSO REPORTED TO THE FDA. THIS OCCURRENCE WAS REPORTED TO US ON 03/18/2022 AND OCCURRED A MONTH PRIOR TO THE AWARE DATE FOR (B)(4) WHICH WAS REPORTED TO THE FDA AS WELL. THE POWER CORD REPLACEMENT ON THE DC-200B FOR THE MEE-2000A MAIN UNIT HAS RESOLVED THE ISSUE. THE RESOLUTION WAS COMPLETED IN COMPLAINT (B)(4). THE MEE-2000A MONITORS, RECORDS, AND DISPLAYS THE BIOELECTRIC SIGNALS PRODUCED BY SENSORY AND MOTOR PATHWAYS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116643 ↗