MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION PE-210AK; SWITCH BOX FOR THE EEG-1200A

Model Number	PE-210AK
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the switch box (pe-210ak, sn: (b)(6)) gave a "the electric stimulator is overloaded" error message while performing a cortical mapping on a patient.They were stimulating lb1-lb2 (left anterior hippocampus) with both low frequency and high frequency stimulation (3 ma for both).With the low frequency stimulation, they heard a crackling noise coming from the stimulation box in addition to seeing artifacts.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.
Event or Problem Description
The biomedical engineer (bme) reported that the switch box (pe-210ak, sn: (b)(6)) gave a "the electric stimulator is overloaded" error message while performing a cortical mapping on a patient.They were stimulating lb1-lb2 (left anterior hippocampus) with both low frequency and high frequency stimulation (3 ma for both).With the low frequency stimulation, they heard a crackling noise coming from the stimulation box in addition to seeing artifacts.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the switch box (pe-210ak, sn: 73) gave a "the electric stimulator is overloaded" error message while performing a cortical mapping on a patient.They were stimulating lb1-lb2 (left anterior hippocampus) with both low frequency and high frequency stimulation (3 ma for both).With the low frequency stimulation, they heard a crackling noise coming from the stimulation box in addition to seeing artifacts.No patient harm was reported.Investigation summary: no patient harm was reported.The complaint device was not returned for evaluation.As such, a device evaluation could not be performed, and a definitive root cause could not be identified.There is also no trend regarding this issue.Without a root cause, countermeasures for the issue could not be identified.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the switch box: eeg system: model #: eeg-1200a-dt serial #: (b)(6) device manufacturer data: 05/10/2019 unique identifier (udi) #:(b)(4) returned to nihon kohden: na.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.
Event or Problem Description
The biomedical engineer (bme) reported that the switch box (pe-210ak, sn: 73) gave a "the electric stimulator is overloaded" error message while performing a cortical mapping on a patient.They were stimulating lb1-lb2 (left anterior hippocampus) with both low frequency and high frequency stimulation (3 ma for both).With the low frequency stimulation, they heard a crackling noise coming from the stimulation box in addition to seeing artifacts.No patient harm was reported.

• Brand Name: PE-210AK
• Common Device Name: SWITCH BOX FOR THE EEG-1200A
• 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: 23136975
• Report Number: 8030229-2025-05553
• Device Sequence Number: 8889240
• Product Code: GYC
• UDI-Device Identifier: 04931921103937
• UDI-Public: (01)04931921103937
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110376
• 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): 12/17/2025

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: PE-210AK
• Device Catalogue Number: PE-210AK
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2014
• 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: EEG SYSTEM; EEG SYSTEM
• Patient Sex: Unknown