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

Model Number	EEG-1200A
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the ups started smoking during the use of the eeg-1200a.The unit was in use on patients at the time, but no patient harm was reported.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 biomedical engineer reported that the ups started smoking during the use of the eeg-1200a.
Additional Manufacturer Narrative
Complaint information: on 05/15/2018, customer at (b)(6) medical center reported ups started smoking during eeg examination.The serial# of ups was (b)(6) with product id: a/abce422-11med service requested: assistance in troubleshooting.Service performed: customer reports that during an eeg, the ups started smoking and then they had to call a code orange and evacuate the room.Nkts requested customer to send ups unit in to repair center and escalated the issue to qa for further investigation.Investigation result: root cause of the issue as per the manufacturer findings was deeply discharged batteries (battery connected without ac power for an extended period of time).When power was applied to the upm, the batteries were in a defective state and swelled.The unit will charge the battery that is weakened, this leads to failure in the battery, causing the battery to exceed battery design limits causing expansion and venting.According to the table in quality complaint investigations work instruction, with document id: sop06-075, the risk priority of the issue is categorized as: medium.Corrective and preventative actions taken: manufacturers have updated firmware to detect severely depleted batteries.The user will be alerted visually via the front panel display.All icons on the display will cycle on and off.The display will continue until the battery is disconnected or ac removed.A field bulletin has been issued describing what steps need to be taken.D11 & c2: the eeg that was being used with the ups had no issue.The issue is with the ups that was being used in conjunction with the eeg.Model: a/abce422-11med.Serial: (b)(6).
Event or Problem Description
The biomedical engineer reported that the ups started smoking during the use of the eeg-1200a.

• 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: 7598830
• Report Number: 8030229-2018-00207
• Device Sequence Number: 19403683
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020
• Report Date (Section F): 02/07/2020

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/06/2020
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UPS
• Date Report Sent to FDA: 02/07/2020