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

Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been requested for return.Further information will be provided when investigation is complete.
Event or Problem Description
Patient claims the sensor burned through his shirt, no harm to the patient was reported.The sensor got heated and burned the patient's shirt.The patient removed the sensor and returned the kit early.
Additional Manufacturer Narrative
It was reported that the sensor burnt through the patient's shirt.The device was returned for investigation and engineering evaluation was performed.Engineering evaluation was unable to replicate the reported complaint.The sensor passed visual inspection however failed functional inspection as the bluetooth test could not be performed.Corrosion identified on the analog printed circuit board likely prevented the device from completing function testing.The reported event is therefore inconclusive.No other problems were found.

• Brand Name: MCOT C6 SENSOR
• Common Device Name: MCOT C6
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan
• MDR Report Key: 16935666
• Report Number: 2133409-2023-00021
• Device Sequence Number: 17597903
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• PMA/510(K) Number: K171410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• 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: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/28/2023; Not provided
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/17/2023; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown