MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT, C6S 3.0 BTH; C6 MCOT

Model Number	02-01846
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and engineering evaluation was completed device was inspected for general physical integrity, no problems found.Device started charge at 1:50pm at 510.7ma, slow blinking yellow led.Device was charged fully at 2:45pm at 27.4ma, solid green led, max temperature at 82.6f, normal.Total device charging time: 55 minutes device charged fully; no problems found.The temperature test was performed, start temperature was 81.0f and after test completion the temperature was 80.4f.Max temperature was 88.4f.No problem found with temperature although the device lost connectivity near the end of the test from the testing computer.It was noted no smell was during either of the heat tests.The device was opened to inspect for damage or burn marks that may have contributed to the melted plastic smell.No problems found.Conclusion: engineering evaluation was unable to confirm an overheating or melted plastic smell.No problems found.
Event or Problem Description
It was reported that sparks from sensor and a burning smell of melted plastic was noted.Additional information was requested with 3 gfe attempts however, no additional information could be obtained.There was no report of death or serious injury.

• Brand Name: UNIT, C6S 3.0 BTH
• Common Device Name: C6 MCOT
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN
• MDR Report Key: 16956080
• Report Number: 2133409-2023-00023
• Device Sequence Number: 16969325
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: B146C6E10
• 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: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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: 02-01846
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/18/2023
• 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