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

Model Number EEG-1260A

Device Problem Structural Problem (2506)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/12/2022

Event Type  Injury  

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

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
• 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
• MDR Report Key: 13530220
• MDR Text Key: 289500085
• Report Number: 2080783-2022-02512
• Device Sequence Number: 1
• Product Code: OLT
• UDI-Device Identifier: 04931921009161
• UDI-Public: 04931921009161
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/14/2022

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2022
• Distributor Facility Aware Date: 01/17/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White