MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION EEG-1260A; NEUROFAX ELECTROENCEPHALOGRAPH

Model Number EEG-1260A

Device Problems Unintended Collision (1429); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/12/2022

Event Type  Injury  

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 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.

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 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.

• Brand Name: EEG-1260A
• Type of Device: 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
• MDR Text Key: 289433019
• Report Number: 8030229-2022-02512
• Device Sequence Number: 1
• Product Code: OLT
• UDI-Device Identifier: 04931921009161
• UDI-Public: 04931921009161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White