MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NEUROMASTER; NEURAL FUNCTION MEASURING SYSTEM

Model Number	DC-110BA
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this system is shutting down throughout the day during procedures.This issue was reported in ticket (b)(4).There was no patient injury 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 are not available (n?a) to this report: h4 device manufacture date.
Event or Problem Description
The customer reported that this system is shutting down throughout the day during procedures.There was no patient injury reported.
Event or Problem Description
The customer reported that this system is shutting down throughout the day during procedures.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this system is shutting down throughout the day during procedures.This issue was reported in ticket (b)(4).There was no patient injury reported.Investigation summary: the device was not returned for evaluation; therefore, a root cause could not be determined.The customer was able to resolve the issue by replacing the cmos battery.The following fields are not available (n/a) to this report: h4 device manufacture date additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h11 additional manufacturer narrative.

• Brand Name: NEUROMASTER
• Common Device Name: NEURAL FUNCTION MEASURING SYSTEM
• 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: 22168091
• Report Number: 8030229-2025-05000
• Device Sequence Number: 7957992
• Product Code: GWF
• UDI-Device Identifier: 04931921102152
• UDI-Public: (01)04931921102152
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051178
• 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,Followup
• Report Date (Section B): 09/19/2025

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: DC-110BA
• Device Catalogue Number: DC-110BA
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NI.; NI.
• Patient Sex: Unknown