MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR 2.0 REBUILT; MCOT SENSOR - 2.0 - REBUILT

Model Number	02-01897
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, that the mcot sensor - 2.0 - rebuilt shocked the patient in the chest.The patient indicated that the sensor was the cause and not the patch.The shock occurred when the patient was at work and it felt like an electric shock.The patient went to the emergency room (er) and wasn't given any medication; however, the doctor advised the patient to switch over to the lead wire adaptor (lwa).The patient does not have any implantable devices and no electronic were at use at the time of the shock.No additional information provided.
Additional Manufacturer Narrative
It was reported mcot sensor - 3.0 shocked the patient in the chest.The sensor was inspected for general physical integrity and found in good condition.Engineering evaluation could not confirm the allegation of sensor shocking the chest.Device evaluation concludes that the sensor operated successfully, and no problem was identified.

• Brand Name: C6 SENSOR 2.0 REBUILT
• Common Device Name: MCOT SENSOR - 2.0 - REBUILT
• 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: 23184385
• Report Number: 2133409-2025-00107
• Device Sequence Number: 9992345
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/02/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01897
• Device Catalogue Number: 02-01897
• 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: 09/06/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female