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

Model Number	EEG-1200A
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their computer turning off unexpectedly during a surgical case.The customer also reported that they were able to recover with minimal data loss and continue recording, but only after having a tech go into the room and turn the recorder back on.
Additional Manufacturer Narrative
The customer reported that their computer turning off unexpectedly during a surgical case.The customer also reported that they were able to recover with minimal data loss and continue recording, but only after having a tech go into the room and turn the recorder back on.No harm or injury was reported.The following non-nkc device was used in conjunction with the eeg-1200a: model: a/dell-7050sff s/n: (b)(4).

• 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
• MDR Report Key: 11571856
• Report Number: 2080783-2021-00174
• Device Sequence Number: 19732713
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2021
• Report Date (Section F): 03/25/2021

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A/DELL-7050SFF-W10
• Date Report Sent to FDA: 03/25/2021