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

Model Number	EEG-1200A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Patient Problem/Medical Problem (2688)
Date of Event	02/28/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer called in because the rn pulled the plug on the equipment, causing the study autocopy to fail.They were requesting assistance copying the studies to the share folder.There is no evidence that the death event is related to the nihon kohden equipment.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 customer reported that a patient expired during an eeg study.
Event or Problem Description
The customer reported that a patient expired during an eeg study.
Additional Manufacturer Narrative
Studies did not copy to share.Service requested.Troubleshooting.Service performed.Troubleshooting.Investigation result: their patient passed away, then the rn pulled the equipment plug from the wall causing the copy to fail.This is considered and ungraceful exit for the equipment.The complaint was to recover the files that did not copy to their share drive.In the adverse event form submitted, the question "how may have a nihon kohden device contributed to the injury or death?" is answered "no".Stating that the nihon kohden equipment was not the cause of the patient's death.This equipment is used for diagnostic purposes, not for monitoring of vital signs.No malfunction was mentioned in the complaint or adverse event form.Based on the given information, this complaint record will be closed as no further investigation is needed at this time.Patient sex.Date of this report: date user facility/importer became aware of the event.Type of report: approximate age of device.Date report sent to fda.Date report sent to manufacturer.Date received by manufacturer.Type of report: if follow-up, what type? additional information: correction.Device evaluated by manufacturer? event problem and evaluation codes the following fields are not applicable (n/a) to this report: the following fields contain no information (ni), as attempts to obtain information were made, but not provided: age at time of the event.Age.Date of birth.Patient weight.Ethnicity.Race.Relevant tests/laboratory data.Other relevant history.Serial #.
Additional Manufacturer Narrative
Corrected data: f7: type of report.G7: type of report.H2: if follow-up, what type (correction or additional or both).H6: even problem and evaluation codes.Additional information: h10: manufacture narrative: details of complaint: studies did not copy to share.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: their patient passed away, then the rn pulled the equipment plug from the wall causing the copy to fail.This is considered and ungraceful exit for the equipment.The complaint was to recover the files that did not copy to their share drive.In the adverse event form submitted, the question "how may have a nihon kohden device contributed to the injury or death?" is answered "no".Stating that the nihon kohden equipment was not the cause of the patient's death.This equipment is used for diagnostic purposes, not for monitoring of vital signs.No malfunction was mentioned in the complaint or adverse event form.

• Brand Name: EEG
• 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: 8460248
• Report Number: 8030229-2019-00077
• Device Sequence Number: 2818810
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2019
• Report Date (Section F): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/12/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019; 07/12/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/16/2019; 07/12/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT APPLICABLE.
• Outcome Attributed to Adverse Event: Death
• Date Report Sent to FDA: 07/12/2019