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

Model Number	MEE-2000A-DT
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a 60 hertz artifact while performing emg surgery.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported a 60 hertz artifact while performing emg surgery.The customer reseated the amp to resolve the issue.Technical support (ts) informed the customer to use the grd cable with alligator clip.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.
Event or Problem Description
The customer reported a 60 hertz artifact while performing emg surgery.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported a 60 hertz artifact while performing emg surgery.The customer reseated the amp to resolve the issue.Technical support (ts) informed the customer to use the grd cable with alligator clip.There was no patient injury reported.Investigation summary: based on the available information, we confirmed the reported issue; however, due to limited information, a definitive root cause could not determined.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: d10 attempt # 1: 12/12/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 12/16/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 12/18/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.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: 21019733
• Report Number: 8030229-2024-04602
• Device Sequence Number: 4008681
• Product Code: GWF
• UDI-Device Identifier: 00841983103612
• UDI-Public: (01)00841983103612
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142624
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: MEE-2000A-DT
• Device Catalogue Number: MEE-2000A-DT
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2021
• 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