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

Model Number	EEG-1200A
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The eeg-1200a is an eeg system.The customer called regarding a system that has not been used in over a year and stated that they just replaced the camera but they could not start the exam.Our technical support spoke with the customer and found that the camera was working but the camera capture unit was overheating.This device is an accessory that is required for the camera to work with the eeg system to record video.We have contacted the customer for additional information but have not received a response from them.Nihon kohden continues to investigate the reported event.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-1200a is an eeg system.The customer called regarding a system that has not been used in over a year and stated that they just replaced the camera but they could not start the exam.Our technical support spoke with the customer and found that the camera was working but the camera capture unit was overheating.This device is an accessory that is required for the camera to work with the eeg system to record video.We have contacted the customer for additional information but have not received a response from them.
Additional Manufacturer Narrative
The eeg-1200a is an eeg system.The customer called regarding a system that has not been used in over a year and stated that they just replaced the camera but they could not start the exam.Our technical support spoke with the customer and found that the camera was working but the camera capture unit was overheating.This device is an accessory that is required for the camera to work with the eeg system to record video.Further investigation cannot be conducted.The current information in the complaint record demonstrates that there were 3 attempts to contact the customer and the customer was not responsive.
Event or Problem Description
The eeg-1200a is an eeg system.The customer called regarding a system that has not been used in over a year and stated that they just replaced the camera but they could not start the exam.Our technical support spoke with the customer and found that the camera was working but the camera capture unit was overheating.This device is an accessory that is required for the camera to work with the eeg system to record video.We have contacted the customer for additional information but have not received a response from them.
Additional Manufacturer Narrative
H10: additional narrative: the customer reported that they replaced the camera with rz25n and are unable to start the exam.The customer later reported that the cam capture box was overheating.Service requested: troubleshooting.Service provided: troubleshooting.Investigation result: the customer was unable to start the exam.The cause of the issue was determined to be raid rebuilding.Re-building of the raid can affect normal functionality of the system.After the raid re-building was completed, the camera worked as intended however, the customer reported the cam capture box was overheating.The cause of the issue could not be determined as the customer was contacted 3 times but would not respond to the call/email to troubleshoot the alleged malfunction, or the customer does not want to cooperate to troubleshoot further.A review of complaint record determines no previously reported complaint was registered with the device a/dell-9010sff;sn:(b)(6) the root cause of the issue was unable to be determined.Corrected information: g4.Date received by manufacturer: should be 10/12/2018 not 11/09/2018 as listed on mdr initial report.

• 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: 8057834
• Report Number: 8030229-2018-00433
• Device Sequence Number: 1746148
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 07/31/2019
• Report Date (Section F): 07/31/2019

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?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2019
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 07/30/2019
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 03/12/2019; 07/31/2019
• 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
• Date Report Sent to FDA: 07/31/2019