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

Model Number	02-02119
Medical Device Problem Codes	Fire (1245); Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported (b)(6) 2025 that on (b)(6) 2025 the wall charger - dual port charger had caught fire, melting and the mcot monitor - a13 - t-mobile was overheating.There was no reported visible flames.The patient stated the monitor was on the charger all night but did not charge.The patient turned the monitor off and attempted to charge but it was charging slowly to 31% within 2.5 hours.The patient stated the wall charger - dual port charger is hot and appears damaged.There was no injuries reported.Patient believed the issue was related to the charger usb port for the mcot sensor - 3.0.No further information can be provided at this time.
Additional Manufacturer Narrative
It was reported (b)(6) 2025 that on (b)(6) 2025 the wall charger - dual port charger had caught fire, melting and the mcot monitor - a13 - t-mobile was overheating.There was no reported visible flames.The patient stated the monitor was on the charger all night but did not charge.The patient turned the monitor off and attempted to charge but it was charging slowly to 31% within 2.5 hours.The patient stated the wall charger - dual port charger is hot and appears damaged.There was no injuries reported.Patient believed the issue was related to the charger usb port for the mcot sensor - 3.0.Philips am&d will further investigate this reported issue.
Additional Manufacturer Narrative
It was reported that the mcot monitor - a13 - t-mobile was charging and the charger caught fire.The monitor returned for investigation.Monitor was inspected for general physical integrity and found the monitor melted in the charging port and around the port area.The red charging cord was returned with the monitor and shows evidence of the burn.In the charge port and the back of the monitor is damaged.Engineering evaluation confirmed the monitor/charge cord melt.Root cause could not be determined.Further investigation is being performed.

• Brand Name: C6 MONITOR A13, T MOBILE
• Common Device Name: MCOT MONITOR - A13 - T-MOBILE
• 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: 22389478
• Report Number: 2133409-2025-00046
• Device Sequence Number: 20596312
• Product Code: DSI
• UDI-Device Identifier: B146C6M80
• UDI-Public: +B146C6M80
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 02-02119
• Device Catalogue Number: 02-02119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WALL CHARGER - DUAL PORT CHARGER,01-02034
• Patient Age: 54 YR
• Patient Sex: Male