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

Device Problems Loss of Power (1475); Smoking (1585); Temperature Problem (3022); Excessive Heating (4030)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

The charger cord component was returned to the manufacturer for investigation.The device and monitor were not returned.The device was inspected for general physical integrity, there was no evidence of burning.A depleted monitor was plugged into the cord to attempt a heat test.The charging cord was unable to provide power to the monitor.Additionally, the usb current meter turned off when the charging cord was plugged energized.The device cover was removed, and wiring was inspected.A fault area was unable to be identified.It was observed that the charging cord had damaged components that may have led to an overheat event.Conclusion: engineering evaluation was unable to confirm overheat.It was observed that the charging cord was nonfunctioning during evaluation.

Event Description

The orange charging cord returned from field burned and started smoking/hot during testing at the distribution center.There was no report of death or serious injury.

• 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
• MDR Report Key: 16593672
• MDR Text Key: 312163536
• Report Number: 2133409-2023-00008
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2023
• 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