MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MONITOR A13, T MOBILE; BRAEMAR TELEMETRY PATCH SYSTEM

Model Number	02-02119
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the mcot monitor - a13 - t-mobile was hot and overheating - possibly smoking.The mcot monitor - a13 - t-mobile was returned for device evaluation.Monitor was inspected for general physical integrity and found to have a melted charge port.The case around the charge port is also melted.No cords were returned for evaluation.The monitor does not power on.No additional testing was completed for safety reasons.Engineering confirmed that the monitor had a melted charge port.Root cause cannot be determined at this time.The monitor has been sent out for further investigation on the cause of damage.
Event or Problem Description
It was reported on (b)(6) 2025 the patient stated the mcot monitor - a13 - t-mobile was hot and overheating and possibly smoking.Additional information was received on 20 march 2025 patient reported they were sleeping but heard a vibration on the monitor and had awaken.There was no reported alert messages displayed on the monitor when the device was vibrating.The patient reported they were charging the monitor when the event occurred and confirmed using the charging cord received in the mcot kit.Patient confirmed the monitor was not smoking because the patient "caught it in time" but thinks the monitor would have smoked if it was left in charging port.There was no reported alleged patient harm or injury as a result of the event.There were no reported property damage or photos to provide.There was no reported photos of the monitor or monitor charging cord available.There was no reported additional electronics in use or plugged in the same outlet at the time of the event.There was no reported device or accessory component(s) exposed to any external environmental temperature conditions prior to the event.There was no reported device or accessory component(s) exposed to moisture prior to the event.No further information can be provided at this time.

• Brand Name: C6 MONITOR A13, T MOBILE
• Common Device Name: BRAEMAR TELEMETRY PATCH SYSTEM
• 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: 21733206
• Report Number: 2133409-2025-00012
• Device Sequence Number: 8735470
• Product Code: DSI
• UDI-Device Identifier: B146C6M80
• UDI-Public: +B146C6M80
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 02-02119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Male