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

Model Number 02-01846

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Device Emits Odor (1425)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

Patient reported that the sensor that was in the universal patch gave an awful smell.The patient also stated that there were burn marks on the patch and the sensor started to melt onto the patch.The patient stated that they removed the patch and sensor and discontinued monitoring.The patient was not harmed.A replacement device was offered however, the patient declined.The device is expected to be returned.

Manufacturer Narrative

It was reported that the sensor gave an awful smell and it was noted that there were burn marks on the patch and sensor.The sensor was returned and investigated engineering evaluation could not replicate the reported event; however, objective evidence provided from the patient does show indication of excess heat experienced between the device contact terminals and universal patch cradle.The root cause of this failure mode is likely due to an accumulation of moisture and or patient sweat at the juncture while device was in use.Device allegation is therefore confirmed for excess heat resulting in burn marks.

• 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: 17729072
• MDR Text Key: 323177589
• Report Number: 2133409-2023-00053
• 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: 01/24/2024

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: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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
• Treatment: 02-01609, UNIVERSAL PATCH V2.0 BLUE.
• Patient Age: 43 YR
• Patient Sex: Male