MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MCOT C6 SENSOR 3.0

Lot Number N/A

Device Problems Smoking (1585); Temperature Problem (3022); Excessive Heating (4030)

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

Event Type  malfunction  

Manufacturer Narrative

There was no report of death or serious injury to patient, operator, or bystander.The device was returned to braemar from biotel heart and was inspected for general physical integrity.The device exhibited evidence of prying and the seal was broken.The device was opened to inspect for additional damage.The battery was observed to have a burn hole in it.It is probable that the battery was damaged during patient misuse.Engineering was able to confirm allegation.The device was badly damaged due to patient misuse.The battery experienced a thermal event that was likely due to the patient/user attempting to pry open the device.

Event Description

It was initially reported by biotel heart that the sensor was getting hot.Additional information was received from patient services: it was reported that the patient placed the sensor with the blue plastic ring from the patch still attached into the charging adapter as is not designed or intended to happen and it was at that time that the sensor started smoking.

• Brand Name: MCOT C6 SENSOR 3.0
• Type of Device: MCOT C6 SENSOR
• 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 MN 56121
• MDR Report Key: 16705051
• MDR Text Key: 312955394
• Report Number: 2133409-2023-00011
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K171410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2023

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 Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1