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

Model Number EEG-1200A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 02/28/2019

Event Type  Death  

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 Description

The customer reported that a patient expired during an eeg study.

Event Description

The customer reported that a patient expired during an eeg study.

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 #.

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
• Type of Device: 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
• MDR Text Key: 140175572
• Report Number: 8030229-2019-00077
• Device Sequence Number: 1
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (y/n): N
• PMA/PMN Number: K080546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 07/12/2019
• Distributor Facility Aware Date: 07/12/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Outcome(s): Death