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

Model Number	02-01846
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Parent reported that the sensor was damaged and began smoking with attempting to pry off the plastic compartment.The patient was struggling to remove sensor from patch at the time of the event.No patient harm was reported.The device was returned and a replacement device was sent.
Additional Manufacturer Narrative
It was reported that the sensor had smoke damage.The device was returned for investigation.A investigation was performed and found that the device was able to charge and device was able to be downloaded and tested.Investigation found that the temperature for the device was within normal limits.Investigation in the log of the device found multiple initialization failed messages.Device was opened to confirm if there was internal damage and corrosion was identified on the pcb boards along with the battery contact on the board.The corrosion can contribute to the device not charging and getting hot.Temperature stress tests could not duplicate the overheat or spark, but there is evidence of sparks and melting on the battery and on the interior and exterior of the sensor.

• 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: 17721814
• Report Number: 2133409-2023-00055
• Device Sequence Number: 12553580
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,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: Other
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 01/04/2023; Not provided
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 01/04/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 74 YR
• Patient Sex: Female