MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MONITOR A10E, VERIZON; BRAEMAR TELEMETRY PATCH SYSTEM

Model Number	02-01804
Medical Device Problem Codes	Fire (1245); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025 that mcot monitor - a10e - verizon was charging and charging cord caught fire and both the monitor and charging cord are now damaged.The patient was not doing any other activities when the incident occurred.It was noted that the patient, patient's husband and property were not injured or damaged.The patient's husband reported that the mcot monitor - a10e - verizon screen is not working properly and the side buttons do not work.The patient services (ps) representative advised the patient and patient's husband to allow the monitor's battery to drain before sending the kit back.A replacement kit was ordered.Additional information was requested however was unsuccessful.
Additional Manufacturer Narrative
It was reported that the mcot monitor - a10e - verizon was charging and caught fire.The device was returned for investigation.Engineering evaluation was able to confirm the allegation of charging cord damage likely as a result of fire or melting.The monitor usb connector port was also damaged as a result of the same thermal event.The root cause could not be determined.The device was sent for further testing; however, additional testing was not able to be performed due to the melt around the charge port.Engineering evaluation confirmed the melt on the charge port of the monitor.

• Brand Name: C6 MONITOR A10E, VERIZON
• 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: 21384927
• Report Number: 2133409-2025-00002
• Device Sequence Number: 8595527
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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
• Patient Age: 77 YR
• Patient Sex: Female