MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR 3.0; MCOT SENSOR - 3.0

Model Number	02-01846
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Headache (1880)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 patient called reported while sleeping having discomfort from wearing the device.Patient stated experiencing headaches, pressure on chest and inquired what should she do.Patient services (ps) recommended to follow-up with their physician.Patient reported that the device caused difficulty breathing, and chest was hurting.The patient contacted their doctor and they instructed the patient to go to the emergency room (er).While the patient was in the er, a ct scan was performed on the patient's lungs.The patient was placed on a new heart monitor and blood work was ran.Everything came back normal.Additional follow up information from patient was provided on (b)(6) 2025.The patient reported the symptoms improved after removing the device.Patient reported the headaches and chest discomfort she experienced 6 months ago.Patient confirmed they were admitted to the hospital from (b)(6) 2025, and did not provide reason for the admission.Patient stated the end results is that they did not find any issues.Patient followed up with the cardiologist and they ran multiple test with no findings and is waiting for a follow-up from cardiologist.He patient believes the device was the cause of the pain and discomfort that they experienced.No further information to provide.
Additional Manufacturer Narrative
It was reported that mcot sensor - 3.0 caused the patient to have discomfort and required the patient to report to the emergency room.He sensor was inspected for general physical integrity and found in good condition.Engineering evaluation could not confirm the allegation of the device caused difficulty breathing and chest was hurting.Sensor passed visual and functional testing.Root cause could not be determined.Device evaluation concludes that the sensor operated successfully, and no problem was identified.

• Brand Name: C6 SENSOR 3.0
• Common Device Name: MCOT SENSOR - 3.0
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 24042360
• Report Number: 2133409-2026-00008
• Device Sequence Number: 10388256
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: Lay User/Patient
• Device Model Number: 02-01846
• Device Catalogue Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female