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

Model Number	02-01894
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device smelt like smoke and was not working.The devcie was returned for engireering investigation.The device was investigated and the engineering evaluation confirmed the reported allegation of "burning smell"; however, it could not replicate the reported allegation of "not able to access functions".Monitor was responsive to touch strokes, no issue with application and touch screen interface.The usb-a to usb-c charge cord was found to be defective.The most likely root cause of the burning smell is from an electrical fault within the cord resulting in a defective usb-a to usb-c monitor charging cord.
Event or Problem Description
It was reported that the montior has a burning smell and the monitor is not working.There was no patient harm reported.A replacement monitor was sent to the patiant.The device returned and it was confirmed that the burning smell was likely due to a electrical fault due to the monitor charging cord.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: C6 MCOT PPM
• Common Device Name: C6 MCOT PPM
• 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: 18083208
• Report Number: 2133409-2023-00068
• Device Sequence Number: 20530298
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/15/2024

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: 02-01894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 07/15/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female