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

Model Number	EEG-1200A
Medical Device Problem Codes	No Audible Alarm (1019); Alarm Not Visible (1022); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the event marker alarms feature e12notify and annot would randomly stop alarming visually and audibly for the eeg1200a systems.The workaround was restarting the study every couple of hours to keep the button working.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.Attempt # 1: 11/20/2023 emailed the customer for the patient information: no reply was received.Attempt # 2: 11/27/2023 emailed the customer for the patient information: the customer responded with as much patient information that they could.
Event or Problem Description
The customer reported that the event marker alarms feature e12notify and annot would randomly stop alarming visually and audibly for the eeg1200a systems.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6)2023, the customer reported that the event marker alarms feature e12notify and annot would randomly stop alarming visually and audibly for the eeg1200a systems.The workaround was restarting the study every couple of hours to keep the button working.No patient harm was reported.Follow up notes: on (b)(6)2023, ts contacted the customer and discovered that the system was working well but stopped working after the sixth hour.After troubleshooting, it was suspected that the customer's antivirus may have blocked the executables for e12notify and annotation.On (b)(6)2023, ts gathered logs for all three machines and discussed them with the customer, who suggested that the issue may be related to shift changes and the checking of system mark buttons.On (b)(6)2023, our neurology engineering services (nes) technician offered to remotely investigate the issue, but the customer asked if upgrading drivers would help.The nes technician recommended upgrading the drivers but was unsure if this was the cause of the issue.After three attempts to follow up with the customer, there was no response, and it is unclear whether the issue was resolved.Investigation summary: nihon kohden was unable to determine a root cause.A possible root cause may be attributed to antivirus issues.Typically, these issues occur due to the antivirus blocking certain important files or programs.Nihon kohden (nk) does not manage exclusions, and customers must set the appropriate exclusions to avoid interfering with nihon kohden products.Our nes technician followed up with the customer on multiple occasions to offer guidance, but the customer did not respond.Although there was patient involvement, there was no injury, no harm, nor any adverse event due to the reported issue.During the review of the device history for the reported issue, it was discovered this device was installed on (b)(6)2020.We found three similar issues for similar devices (product id: a/dell-7050sff-w10) with separate serial numbers that occurred at this facility around the same time frame.These similar complaints were discovered over the past four years and are as follows: ticket(b)(4).(reported on (b)(6)2023 for serial number (b)(6), ticket (b)(4).(reported on (b)(6)2023 for serial number (b)(6), and ticket(b)(4).(reported on (b)(6)2023 for serial number (b)(6).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.Moreover, since (b)(6)2023, no further similar issues have been reported by this facility for this device.Nk will continue to monitor trends for this device and facility for similar complaint issues.Attempt # 1: (b)(6) 2023 emailed the customer for the patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer for the patient information: the customer responded with as much patient information that they could.
Event or Problem Description
The customer reported that the event marker alarms feature e12notify and annot would randomly stop alarming visually and audibly for the eeg1200a systems.No patient harm was reported.
Event or Problem Description
The customer reported that the event marker alarms feature e12notify and annot would randomly stop alarming visually and audibly for the eeg1200a systems.No patient harm was reported.
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.

• 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: 18239127
• Report Number: 8030229-2023-03923
• Device Sequence Number: 7160626
• 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: 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: 11/01/2023
• Supplement Date Received by Manufacturer: 02/16/2024; 02/16/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/19/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2019
• 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
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Race: White