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

Model Number	02-02118
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the wall charger - dual port charger melted and damaged the mcot monitor - a13 - verizon while charging overnight.The patient noted that the mcot monitor - a13 - verizon was plugged directly into the wall outlet and nothing else was plugged into the outlet.The patient was not harmed.The patient returned the kit and a replacement was sent.No additional information was provided.
Additional Manufacturer Narrative
It was reported that the mcot monitor - a13 - verizon melted why charging with the wall charger - dual port charger.The device was returned for evaluation.Engineering evaluation was able to confirm the reported event of "charging cable melted and damaged the monitor".Thermal damage was identified on both the monitor and charging cable.A definitive root cause could not be established.Am&d philips is further investigating this issue.

• Brand Name: C6 MONITOR A13, VERIZON
• Common Device Name: MCOT MONITOR - A13 - 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: 22185607
• Report Number: 2133409-2025-00021
• Device Sequence Number: 8571059
• Product Code: DSI
• UDI-Device Identifier: B146C6M90
• UDI-Public: +B146C6M90
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 02-02118
• Device Catalogue Number: 02-02118
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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: 36 YR
• Patient Sex: Female