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

Model Number	EEG-1260A
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
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
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.

• Brand Name: EEG-1260A
• 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
• MDR Report Key: 13530220
• Report Number: 2080783-2022-02512
• Device Sequence Number: 4039762
• Product Code: OLT
• UDI-Device Identifier: 04931921009161
• UDI-Public: 04931921009161
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/14/2022
• Report Date (Section F): 02/14/2022

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 02/14/2022