MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NEUROFAX; NEUROFAX ELECTROENCEPHALOGRAPH

Model Number	EEG-1200A
Medical Device Problem Codes	Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The eeg technician reported that they had a camera outage in their emu room 2 at 2:30 am on 11/30/2023 and the recording camera window was black on both the monitoring technician's side and the acquisition machine.The eeg technician closed out of their program and watched the patient.They rebooted the emu room 2 computer and waited for it to fully load, restarted the acquisition to make sure they were able to see the video during acquisition.No patient harm was reported.
Additional Manufacturer Narrative
The eeg technician reported that they had a camera outage in their emu room 2 at 2:30 am on 11/30/2023 and the recording camera window was black on both the monitoring technician's side and the acquisition machine.The eeg technician closed out of their program and watched the patient.They rebooted the emu room 2 computer and waited for it to fully load, restarted the acquisition to make sure they were able to see the video during acquisition.No patient harm was reported.Eeg technician did not provide the serial number of the eeg-1200a system so the manufacturer date and serial number is blank.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 eeg technician reported that they had a camera outage in their emu room 2 at 2:30 am on 11/30/2023 and the recording camera window was black on both the monitoring technician's side and the acquisition machine.The eeg technician closed out of their program and watched the patient.They rebooted the emu room 2 computer and waited for it to fully load, restarted the acquisition to make sure they were able to see the video during acquisition.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the eeg technician reported that they had a camera outage in their emu room 2 at 2:30 am on (b)(6) 2023 and the recording camera window was black on both the monitoring technician's side and the acquisition machine.The eeg technician closed out of their program and watched the patient.They rebooted the emu room 2 computer and waited for it to fully load, restarted the acquisition to make sure they were able to see the video during acquisition.No patient harm was reported.Eeg technician did not provide the serial number of the eeg-1200a system so the manufacturer date and serial number is blank.Investigation summary: root cause analysis: we determined the root cause to be power related issues.Since the customer stated the camera experienced an outage, our nes technician recommended performing a generator test.A power generator test includes a series of evaluations designed to make certain each component is functioning optimally.Typically, power related issues occur due to power outages at the customer's facility or sudden surges in power, however, a definitive root cause of the outage could not be determined due to lack of information provided by the customer.Device history review: a review of historical data does not reveal a significant trend that would contribute to component failure that is related to the design or manufacturing of the device.We will continue to monitor trends for this device and facility for similar complaint issues.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a4 patient weight attempt # 1: 12/15/2023 emailed the customer via microsoft outlook for patient information: reply was received and the eeg technician provided the a2- a6 fields.Additional information: b4 date of this report d4 additional device information/serial number g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer h4 device manufacturer date h6 event problem and evaluation codes h11 additional manufacturer narrative.
Additional Manufacturer Narrative
**udi related data quality updates** corrected information: d1 brand name: corrected the brand name from eeg-1200a to neurofax.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.Additional information: b4 data of this report g6 type of report h2 if follow up, what type?.
Event or Problem Description
The eeg technician reported that they had a camera outage in their emu room 2 at 2:30 am on (b)(6) 2023 and the recording camera window was black on both the monitoring technician's side and the acquisition machine.The eeg technician closed out of their program and watched the patient.They rebooted the emu room 2 computer and waited for it to fully load, restarted the acquisition to make sure they were able to see the video during acquisition.No patient harm was reported.

• Brand Name: NEUROFAX
• Common Device Name: NEUROFAX 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: 18378139
• Report Number: 8030229-2023-03968
• Device Sequence Number: 7579729
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: (01)04931921110904
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2024

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: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/20/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2020
• 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: JUNCTION BOX - JE-921A; JUNCTION BOX - JE-921A; JUNCTION BOX - JE-921A; PC - OPTIPLEX XE3; PC - OPTIPLEX XE3; PC - OPTIPLEX XE3
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian