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

Model Number	EEG-1200A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/17/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer reported that a patient had expired while being connected to our machine.No malfunction of the eeg device was reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
Event or Problem Description
The customer reported that a patient had expired while being connected to our machine.
Event or Problem Description
The customer reported that a patient had expired while being connected to our machine.
Additional Manufacturer Narrative
Additional narrative: on (b)(6) 2018, (b)(6) reported the ptz controls were off the screen.Service requested/performed: information was provided to the customer to get the controls back onto the screen and resolve the issue.There was a report of a patient death while connected to the machine.The customer was contacted multiple times to obtain additional information regarding the incident.Missing information: information regarding the patient incident is missing due to lack of customer response.Investigation result: the root cause of the ptz issue is due to user error/education.The customer was not aware of the steps to take to return the controls to the screen.The device was in use on a patient and there was a report of patient death.However, there was no information to indicate the patient death was due to a device malfunction or deficiency.This device is used for diagnostic purposes and not monitoring of vital signs.Per attached mdr decision tree, the ptz issue is not likely to cause or contribute to a death or serious injury.Based on the given information, this complaint record can be considered low risk and will be closed as no further investigation is needed at this time.Corrected information: date received by manufacturer: should be 04/17/2018 not 05/16/2018 as listed on mdr initial report additional information: date of this report, serial #, health professional? occupation, 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? device manufacture date, event problem and evaluation codes, additional manufacturer narrative.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: the customer did not initially respond to follow up requests.Contact with the customer was finally made, however, no information was provided.Age at time of event, date of birth, sex, weight, ethnicity, race, relevant tests/laboratory data, including dates, other relevant history, including preexisting medical conditions.

• 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: 7520252
• Report Number: 8030229-2018-00158
• Device Sequence Number: 1164712
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 07/22/2019
• Report Date (Section F): 07/22/2019

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: 07/22/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 07/22/2019
• 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: 07/22/2019