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

Model Number	02-01606
Medical Device Problem Codes	Overheating of Device (1437); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that while charging the sensor a purple light came on and when the sensor was removed from the charger it was noted the sensor was hot and there were burn marks.The device was returned.Device was inspected for general physical integrity and found device was melted by the bottom contacts.The device has a crack on the front left side and is cracked over the qr code and continues down to the center contacts.Device was not able to be heat stress tested or ats (automated test system) due to the melting near the contacts.The battery is bulging and cracking the enclosure of the sensor.The sensor was opened to see if there was internal damage and found corrosion on all the boards.The battery has expanded and has signs of moisture under the yellow tape.Allegation is confirmed.
Event or Problem Description
It patient reported that they charged the snesor and the purple light came on the sensor.The patient took the sensor off the charger and reported that the sensor was hot and had burn marks on the sensor.The patient was concerned that data was not being sent and that the sensor was not working.The patient services rep confirmed that (b)(6) 2023 was the last day data was received.The patient was advised to return the device.A replacement kit was ordered and their service was extended.No patient harm was repoted to the patient.

• 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: 18566937
• Report Number: 2133409-2024-00003
• Device Sequence Number: 6810866
• Product Code: DSI
• UDI-Device Identifier: B146C6D10
• UDI-Public: +B146C6D10
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/03/2024

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: 02-01606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• 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: 82 YR
• Patient Sex: Female