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

Model Number	02-02387
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	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2026 that the mcot monitor - a13 - t-mobile and charger had caught fire and showed melting.Incident date provided was (b)(6) 2026.Patient did not sustain any injuries so no medical attention was sought.Issue was related to the monitor and charger.Patient's activity at the time was monitor was on kitchen counter charging with the charger that came inside the kit.Patient refused replacement and would like to early disconnect.Advised on return instructions.No additional information was provided.

• 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: 25472292
• Report Number: 2133409-2026-00104
• Device Sequence Number: 10425916
• Product Code: DSI
• UDI-Device Identifier: B146C6M80
• UDI-Public: +B146C6M80/$$+7MT300027466
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 10/01/2026

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: 02-02387
• Device Catalogue Number: 02-02387
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHARGING CABLE - MONITOR - A TO C, 01-01970
• Patient Age: 82 YR
• Patient Sex: Male