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

Model Number	02-01894
Medical Device Problem Codes	Fire (1245); Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
T was reported on (b)(6) 2025, that the patient stated device charger caught on fire.Patient stated red cable was plugged in with monitor, monitor was not charging when plugged in, patient stated she smelled smoke, when she unplugged it was hot, usb c port that was plugged into phone was sparking.Patient stated there was no property damage.Patient stated allegation had too do with charging block and red cable.Patient was charging device at the time of allegation.Patient was sent a replacement.The patient did not seek any medical attention.The patient stated there were no other electronics plugged in the outlet at the time of the event.The patient does live in florida, so y can be very humid and hot.No additional information was provided.
Additional Manufacturer Narrative
It was reported that the mcot monitor - a10e - verizon-unlocked was charging when the charging cable - monitor - a to c caught fire.The device was returned for evaluation.Engineering evaluation confirmed the monitor/charge cord melt.Root cause could not be determined.Am&d philips is further investigating this reported issue.

• 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: 23515795
• Report Number: 2133409-2025-00150
• Device Sequence Number: 9786096
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/27/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHARGING CABLE - MONITOR - A TO C, 02-01894
• Patient Age: 39 YR
• Patient Sex: Female