MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION EEG-1200A; NEUROFAX ELECTROENCEPHALOGRAPH

Model Number	EEG-1200A
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The monitor technician reported that there was a burning smell from the system.They did some troubleshooting and found that the power supply inside the computer was causing the smell.They replaced the part with the nihon kohden provided part number for the replacement power supply.Issue was resolved by the customer.This was not in patient use and no other devices being used with the system.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 monitor technician reported that there was a burning smell from the system.They did some troubleshooting and found that the power supply inside the computer was causing the smell.They replaced the part with the nihon kohden provided part number for the replacement power supply.Issue was resolved by the customer.This was not in patient use.
Event or Problem Description
The monitor technician reported there was a burning smell coming from the system.They did some troubleshooting and found that the power supply inside the computer was causing the smell.They replaced the part with the nihon kohden provided part number for the replacement power supply.Issue was resolved by the customer.This was not in patient use.
Additional Manufacturer Narrative
Details of complaint: the monitor technician reported there was a burning smell coming from the system.They performed some troubleshooting and found that the power supply inside the computer was causing the smell.No harm or injury was reported.Investigation summary: the customer reported that the issue was resolved by replacing the power supply on the pc.The device was installed at the customer's facility on approximately 10/2014.The device was not returned for evaluation, so a root cause cannot be determined.Due to the age of the device, the root cause is most likely related to wear and tear and aging of the power supply.Complaint history review revealed that this is incident is the only incident regarding smell to have occurred with eeg systems.This is deemed to be an isolated incident.No further issues were reported.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.

• Brand Name: EEG-1200A
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12222735
• Report Number: 8030229-2021-01464
• Device Sequence Number: 3751417
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/24/2023

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: 06/24/2021
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/24/2021
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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
• Patient Sex: Unknown