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

Model Number	02-01846
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Chest Pain (1776); Tissue Breakdown (2681)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, the mcot sensor - 3.0 shocked the patient and was causing chest pain, breast tenderness and visible sores.The patient took aspirin to treat the chest pain and later sought medical attention.The patient was then prescribed triamcinolone cream.The patient reported that the sensor was operational after the shock and that they had never experiences these symptoms prior to the event.No additional information was provided.
Additional Manufacturer Narrative
It was reported that the mcot sensor - 3.0 shocked the patient.The sensor was returned for investigation.The sensor was inspected for general physical integrity and found to have most of the blue seal around the back of the sensor has been removed.Due to the damage of the blue seal, the sensor was opened to inspect internal components for damage or corrosion.No damage or corrosion was found on the internal components.Engineering evaluation could not confirm the allegation of sensor shocked her and created event with chest pain.The sensor did have damage to the blue seal around the back of the sensor.Device evaluation concludes that the sensor operated successfully, and no problem was identified.(b)(4) will address the skin irritation.

• 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: 22771259
• Report Number: 2133409-2025-00070
• Device Sequence Number: 9185276
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/03/2025

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?: Yes
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL, 02-01609.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female