MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR 3.0; MCOT SENSOR - 3.0

Model Number	02-01846
Medical Device Problem Codes	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
Additional Manufacturer Narrative
It was reported on (b)(6) 2025 that the charging cable - sensor charge adapter was overheating and melting.The patient reported the charger started to catch fire and there was no visible flames.The patient believed that the event was related to the usb port of the mcot sensor - 3.0.The patient reported no injuries occurred.Philips am&d is further investigating this reported issue.
Event or Problem Description
It was reported on (b)(6) 2025 that the charging cable - sensor charge adapter was overheating and melting.The patient reported the charger started to catch fire and there was no visible flames.The patient believed that the event was related to the usb port of the mcot sensor - 3.0.The patient reported no injuries occurred.No further information can be provided at this time.
Additional Manufacturer Narrative
It was reported that the mcot sensor - 3.0 charger caught fire.There were no visible flames.The sensor charge adapter charging cable, c6 monitor and the dual port wall charger were not returned with the device.Without the original accessories, a comprehensive root cause evaluation cannot be performed.The c6 mcot sensor was inspected for general integrity and there was some minor discoloration on the contact terminals.No objective evidence was provided by the patient to confirm the reported event.Engineering evaluation was unable to confirm the reported event of "sensor charging overheating and melting." the dual port wall charger and sensor charge adapter charging cable were not returned for evaluation and could not be ruled out as a potential root cause.The sensor passed all functional testing.A definitive root cause could not be established.

• Brand Name: C6 SENSOR 3.0
• Common Device Name: MCOT SENSOR - 3.0
• 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: 22387693
• Report Number: 2133409-2025-00045
• Device Sequence Number: 15217198
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: 02-01846
• Device Catalogue Number: 02-01846
• 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: 01/16/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 - SENSOR CHARGE ADAPTER, 02-00109
• Patient Age: 63 YR
• Patient Sex: Female