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

Model Number	02-01549
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported by biotel heart that the charging port was melted.There was no report of death or serious injury to patient, operator, or bystander.
Additional Manufacturer Narrative
Engineering conducted an investigation on the returned device.It was inspected for general physical integrity and passed.The device began charging at 8:30am at 1494.6ma.Device finished charging at 10:22am at 402.5ma.No problems found.The device drew normal amount of current and max temperature was 88.8f.Device charging cord was not returned for evaluation.Any alleged melting was not likely due to issues with the monitor.Device charging port was inspected; no damage was noted.Conclusion: engineering evaluation was unable to confirm charging cord melt.The monitor showed no signs of issue.

• Brand Name: MCOT C6 MONITOR
• Common Device Name: MCOT C6 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 dr; suite 150; eagan MN 56121
• MDR Report Key: 16809499
• Report Number: 2133409-2023-00018
• Device Sequence Number: 3061731
• Product Code: DSI
• UDI-Device Identifier: B146C6M40
• UDI-Public: B146C6M40
• Combination Product (Y/N): N
• PMA/510(K) Number: K171410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: 02-01549
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/25/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown