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

Model Number	EEG-1260A
Medical Device Problem Codes	Unintended Collision (1429); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported that their staff bumped into the eeg card, causing the camera to fall of the pole onto their radiology staff ankle.The camera still works as intended.There was no patient involvement at the time when this occurred.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.Attempt # 1: on 01/28/2022 emailed the customer via (b)(6) for patient information: an "unknown" answer was received.
Event or Problem Description
The customer reported that their staff bumped into the eeg card, causing the camera to fall of the pole onto their radiology staff ankle.The camera still works as intended.There was no patient involvement at the time when this occurred.
Additional Manufacturer Narrative
Details of complaint: the customer reported that a staff member bumped into the eeg cart, causing the camera to fall from the pole onto their radiologist's ankle.The camera still worked as intended.There was no patient involvement at the time.Investigation summary: the customer reported that the system was checked and there were no loose components.They were not able to recreate how the event occurred.It was reported that a staff member bumped into the eeg cart with radiology equipment and the camera impacted another staff member.As such, the root cause is likely related to use error and mishandling.This event is likely an isolated incident.The eeg cart likely moved or tipped over as a result of being bumped.There is no evidence of an nk device malfunction that may have contributed to the reported issue.The following field contains no information (ni), as an attempt to obtain the information was made, but not provided: a-4 attempt # 1: 01/28/2022 emailed the customer via microsoft outlook for patient information: the customer replied that the information was unknown.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.
Event or Problem Description
The customer reported that a staff member bumped into the eeg cart, causing the camera to fall from the pole onto their radiologist's ankle.The camera still worked as intended.There was no patient involvement at the time when this occurred.
Event or Problem Description
The customer reported that a staff member bumped into the eeg cart, causing the camera to fall from the pole onto their radiologist's ankle.The camera still worked as intended.There was no patient involvement at the time when this occurred.
Additional Manufacturer Narrative
Udi related data quality updates corrected information: d1 brand name: corrected the brand name from eeg-1260a to neurofax.D4 serial number: corrected the serial number from (b)(6).D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.Additional information: b4 data of this report g6 type of report h2 if follow up, what type?.

• Brand Name: NEUROFAX
• Common Device Name: NEUROFAX ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13530221
• Report Number: 8030229-2022-02512
• Device Sequence Number: 17153708
• Product Code: OLT
• UDI-Device Identifier: 04931921009161
• UDI-Public: (01)04931921009161(21)48
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K080546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2024

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-1260A
• Device Catalogue Number: EEG-1260A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 10/25/2023; 10/25/2023
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 10/26/2023; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White