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

Device Problems Overheating of Device (1437); Temperature Problem (3022); Excessive Heating (4030)

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

Event Date 05/09/2023

Event Type  malfunction  

Manufacturer Narrative

Product has been requested for return.Further information will be provided when investigation is complete.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 315300467
• Report Number: 2133409-2023-00021
• 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,Followup
• Report Date: 07/14/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/17/2023
• 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