MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NEUROFAX; ELECTROENCEPHALOGRAPH

Model Number	EEG-1260A
Medical Device Problem Codes	Smoking (1585); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that ups used with the eeg started smoking when it was powered on.This was an out of box failure.No patient harm was 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.Powervar ups.A/abce422-11med.Sn ni.
Event or Problem Description
The customer reported that ups used with the eeg started smoking when it was powered on.This was an out of box failure.No patient harm was reported.
Event or Problem Description
The customer reported that ups used with the eeg started smoking when it was powered on.This was an out of box failure.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that ups used with the eeg started smoking when it was powered on.This was an out of box failure.No patient harm was reported.Investigation conclusion: the complaint device is not available for evaluation.Without the device evaluation, the root cause of the issue could not be determined.Powervar ups.A/abce422-11med.Sn ni.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.

• 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: 23069320
• Report Number: 8030229-2025-05512
• Device Sequence Number: 9866631
• Product Code: OLT
• UDI-Device Identifier: 04931921009161
• UDI-Public: (01)04931921009161
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/13/2026

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-1260A
• Device Catalogue Number: EEG-1260A
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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: A/ABCE422-11MED UPS; A/ABCE422-11MED UPS
• Patient Sex: Unknown