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

Model Number	EEG-1200A
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The eeg tech reported the eeg / psg combo system "popped and started smelling like something was burnt." qa along with service reviewed the pc and the computer would not turn on, only the amber light was flashing.There was not burning smell.The unit was then evaluated by the service, and they concluded that the power supply was bad.The power supply was replaced and the unit was burned-in for 72 hours and everything tested fine.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The eeg tech reported the eeg / psg combo system "popped and started smelling like something was burnt.".
Additional Manufacturer Narrative
Additional information: type of report? if follow-up, what type? details of complaint: customer called and reported her eeg/polysmith system 'popped and started smelling like something was burnt.Unit was sent in for evaluation.Service requested: repair/loaner.Service performed: troubleshooting.Investigation result: reviewed the pc with repair center and the computer would not turn on, only the amber light was flashing.There was no burning smell.Requested the repair center continue with troubleshooting pc.Qa/repair center has evaluated the burning smell that came from power supply burning.Replace the power supply.Reapply the cpu paste.Check the eeg test.

• Brand Name: EEG-1200A
• Common Device Name: NEUROFAX ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7087049
• Report Number: 8030229-2017-00424
• Device Sequence Number: 13755505
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017
• Report Date (Section F): 12/06/2017

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: Medical Technologist
• Device Model Number: EEG-1200A
• Device Catalogue Number: EEG-1200A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2017
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/06/2017