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

Lot Number N/A

Device Problems Fire (1245); Temperature Problem (3022); Excessive Heating (4030)

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

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

The monitor was returned to the manufacturer, but not the charger cord component.Engineering evaluation was completed by on 28feb2023.Results are as follows: device was inspected for general physical integrity, charging port was partially melted.Device started charge at 7:00am at 1463.8ma.Device was charged fully at 8:58am at 352.8ma max temperature at 86.0f, normal.Total device charging time: 1 hour and 58 minutes device charged fully; no problems found.Heat stress blue tooth test was performed.Test started at 9:25am and completed test at 10:55am.Max temperature was 84.0f.No problems found.Device was opened inspect the printed circuit board near the charging port.No damage found.It is unlikely that the monitor was the source of the melt event.Conlusion: engineering evaluation was able to confirm a melt event.It is unlikely that the monitor contributed to the event.It is most probable that a fault event occurred with the charging cord.However, the charging cord was not returned and was discarded.

Event Description

Biotel heart customer support reported that the monitor and orange charging cord on fire and sparking there was no report of death or serious injury.Replacement was ordered for patient to continue enrollment.

• Brand Name: MCOT C6 MONITOR
• Type of Device: MCOT C6 MONITOR
• 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
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 16524713
• MDR Text Key: 311088652
• Report Number: 2133409-2023-00006
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2023

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?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/10/2023
• 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