MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MONITOR A10E, VERIZON; MCOT MONITOR - A10E - VERIZON-UNLOCKED

Model Number	02-01894
Medical Device Problem Codes	Failure to Charge (1085); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the mcot monitor - a10e - verizon-unlocked overheating while charging and failed to charge.The mcot monitor - a10e - verizon-unlocked returned for device evaluation.Monitor was inspected for general physical integrity and found the back of the monitor had a melt at the bottom of the device close to the charge port.The charge port also showed signs of the melt.The monitor charging cord had evidence of a thermal event.See attached pictures of damage.Engineering evaluation could confirm the allegation on the monitor overheating leading to a melt.Root cause could not be determined.The monitor was sent for further testing.
Event or Problem Description
It was reported that on (b)(6) 2025, the mcot monitor - a10e - verizon-unlocked got really hot overnight and did not seem to be charging.The patient noted the next morning on (b)(6) 2025, the monitor was only at 65%, the monitor said it was overheating and the screen was bright white and said that it should be shut down.The patient said it did not appear to be hot to the touch and there was no physical damage noted.The patient confirmed they were using the charging cords that were provided in the kit.To the patient's knowledge there was no moisture exposure to the monitor prior to the overheating event.No additional information was provided.

• Brand Name: C6 MONITOR A10E, VERIZON
• Common Device Name: MCOT MONITOR - A10E - VERIZON-UNLOCKED
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan, mn 55121 ; FR 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: 24038500
• Report Number: 2133409-2026-00007
• Device Sequence Number: 9057778
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: 02-01894
• Device Catalogue Number: 02-01894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female