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

Model Number	02-01804
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported on (b)(6) 2025, the mcot monitor - a10e - verizon overheated and emitted smoke while on the dresser.The patient was sleeping and was not wearing the device at the time of the incident.The device overheated, made a loud noise and emitted smoke.There was no injury to the patient.The patient returned the equipment and was sent a replacement.Philips am&d will further investigate this reported issue.
Event or Problem Description
It was reported on (b)(6) 2025, the mcot monitor - a10e - verizon overheated and emitted smoke while on the dresser.The patient was sleeping and was not wearing the device at the time of the incident.The device overheated, made a loud noise and emitted smoke.There was no injury to the patient.The patient returned the equipment and was sent a replacement.No further information to provide.
Additional Manufacturer Narrative
It was reported that the mcot monitor - a10e - verizon overheated and emitted smoke.The device was returned for investigation.Monitor was inspected for general physical integrity and found to have multiple impact cracks on the display.The charge port did have debris but did not show any signs of melting or burning.Engineering evaluation could not replicate the allegation of monitor overheat but could see damage on the display of the device.Root cause is likely customer abuse since the monitor has impact damage cracks.

• Brand Name: C6 MONITOR A10E, VERIZON
• Common Device Name: MCOT MONITOR - A10E - 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: 22613472
• Report Number: 2133409-2025-00064
• Device Sequence Number: 18668616
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,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: 02-01804
• Device Catalogue Number: 02-01804
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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: 58 YR
• Patient Sex: Male