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

Model Number	02-01894
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the mcot monitor, a10e verizon unlocked, overheated and would not power off.The device was returned for investigation.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.The monitor does not power on and is unable to be charged due to the melt.Engineering evaluation could confirm the allegation on the monitor overheating leading to a melt.Root cause could not be determined.
Event or Problem Description
It was reported that on (b)(6) 2025 the mcot monitor, a10e verizon unlocked, overheated and would not power off.A replacement was sent.Additional information was requested but could not be obtained.

• 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
• 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: 24415558
• Report Number: 2133409-2026-00026
• Device Sequence Number: 10608047
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/23/2026

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: 08/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: 60 YR
• Patient Sex: Male