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

Model Number 02-01846

Device Problems Fire (1245); Overheating of Device (1437)

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

Event Date 12/27/2023

Event Type  malfunction  

Event 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.

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.

• Brand Name: C6 MCOT PPM
• Type of Device: 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
• MDR Text Key: 333658147
• Report Number: 2133409-2024-00004
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male