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

Model Number EEG-1200A

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2021

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 281999253
• Report Number: 8030229-2021-01464
• Device Sequence Number: 1
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1