MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MONITOR A13, VERIZON; MCOT MONITOR - A13 - VERIZON

Model Number	02-02118
Medical Device Problem Codes	Overheating of Device (1437); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the mcot monitor - a13 - verizon fell and the charger got jammed in the charging port and the monitor overheated.The monitor returned for investigation.Monitor was inspected for general physical integrity and found the monitor and charger cable melted and fused together in the charging port.Further investigation is being conducted.Engineering evaluation confirmed the monitor/charge cord melt.Root cause could not be determined.
Event or Problem Description
It was reported that overnight on 23 february into 24 february 2025 the mcot monitor - a13 - verizon fell on the floor and became damaged.The patient noted that after the monitor fell on the floor, the charger was jammed in the bottom at the charging port.The patient could not pull the charger out.The patient also noted that the monitor became very hot and the overheating warning message appeared on the monitor's screen.It unplugged the charging adapter and powered the monitor off.Additional information was provided that the monitor did work after the incident and the patient was shipped a replacement.No additional information provided.

• Brand Name: C6 MONITOR A13, VERIZON
• Common Device Name: MCOT MONITOR - A13 - VERIZON
• 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: 23782156
• Report Number: 2133409-2025-00174
• Device Sequence Number: 9521407
• Product Code: DSI
• UDI-Device Identifier: B146C6M90
• UDI-Public: +B146C6M90
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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: 02-02118
• Device Catalogue Number: 02-02118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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: Male