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

Model Number 02-01846

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 323103246
• Report Number: 2133409-2023-00055
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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
• Device Operator: Other
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female