MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NEUROFAX; ELECTROENCEPHALOGRAPH

Model Number	EEG-1200A
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the eeg technician reported that the artifact was not shown correctly during a procedure and the patient had no response to the stimulation when they should have.They tried using a different grass stim system and the patient responded to that one.It was noted there was a difference in pulse width from our system to the grass system.There was no patient harm reported.Investigation summary: additional troubleshooting was performed by nk neurology engineering services, and the troubleshooting suggested that the nk ms-120bk device was causing the issue.The complaint device is not available for evaluation.The customer stated that they would purchase a new ms-120bk device and would not send the device for repair as it is out of warranty.Without the evaluation of the complaint unit, a definitive root could not be identified.Nk will continue to monitor and trend for this issue.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the eeg-1200aa: stimulator: model #: ms-120bk, serial #: (b)(6), device manufacturer data: ni, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.
Event or Problem Description
The eeg technician reported that the artifact was not shown correctly during a procedure and the patient had no response to the stimulation when they should have.They tried using a different grass stim system and the patient responded to that one.It was noted there was a difference in pulse width from our system to the grass system.There was no patient hard reported.

• Brand Name: NEUROFAX
• Common Device Name: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 22302394
• Report Number: 8030229-2025-05034
• Device Sequence Number: 20980960
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: (01)04931921110904
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EEG-1200A
• Device Catalogue Number: EEG-1200A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STIMULATOR, MS-120BK, NO SN COULD BE OBTAINED
• Patient Sex: Unknown