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

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	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the monitor was charging and overheated and melted c6 mcot monitor case.The c6 monitor was returned for investigation.Monitor was inspected for general physical integrity and showed evidence of the charge port melted.No other area of the monitor was damaged.Monitor did power on during testing and gave an error for a damaged cable while using the testing charge cord.Monitor then began to charge but due to the damage, did not complete the whole charge.A charge cord that was used with this device was not returned with the monitor.Engineering evaluation confirmed the device melted and caused damage to the charge port.The charge cord that was returned with the device was not the one that melted with the monitor.Root cause could not be determined without the original cord being returned with the device.
Event or Problem Description
It was reported that on 21 may 2024 the patient's husband was charging the mcot monitor and it heated up and melted the phone case.It was confirmed that no injuries were reported and the monitor was not operational after the overheating event.The monitor was powered off and everything was placed back in the box to be returned.A replacement was ordered.

• Brand Name: C6 MONITOR A10E, VERIZON
• Common Device Name: MCOT MONITOR
• 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: 19558762
• Report Number: 2133409-2024-00038
• Device Sequence Number: 4812020
• Product Code: DSI
• UDI-Device Identifier: B146C6M90
• UDI-Public: +B146C6M90/$$+7MT310214837
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female