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

Model Number	02-01846
Medical Device Problem Codes	Fire (1245); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sensor burned and started to catch fire while charging in the charger.The charger was plugged with an extension cord.The patient services rep instructed the patient with proper charging instructions.A return kit was requested and a replacement was order.There were no injuries or property damage reported.
Additional Manufacturer Narrative
It was reported that the sensor melted and started on fire when charging.The sensor was returned for investigation.Engineering evaluation found the outer case was severely melted in the area of the usb voltage contact.Corrosion was identified between contact pins on the analog pcb, this most likely caused a fault that resulted in a melt event.Liquid ingress most likely caused the extensive corrosion.Based on engineering evaluation, the reported event was confirmed.A definitive root cause could not be confirmed, but the most probable root cause is user error.The user should insert the sensor properly into the patch, not submerge in water, not expose to water when configured without the patch, and not use an extension cord.
Additional Manufacturer Narrative
Correction: d4.

• Brand Name: C6 MCOT PPM
• Common Device Name: UNIT,C6S 3.0,BTH
• 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: 18576723
• Report Number: 2133409-2024-00004
• Device Sequence Number: 21122976
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/02/2024

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: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: 69 YR
• Patient Sex: Male