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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MCOT C6 MONITOR
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BRAEMAR MANUFACTURING, LLC MCOT C6 MONITOR Back to Search Results
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  
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.
 
Manufacturer Narrative
The device was retuned for further investigation.Device was inspected for general physical integrity, charging cord was burnt externally.Device was plugged into a monitor to measure the temperature.Temperature saw a steady increase to 83.6f after 40 minutes.Test was stopped in order to avoid further damaging cord.Device cover was removed and wiring was inspected.Red wire showed evidence of overheating/possible fault.Template.Conclusion: engineering evaluation was able to confirm overheat.Root cause is likely and electrical fault causing an overheat event.
 
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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 Key16593843
MDR Text Key312208523
Report Number2133409-2023-00009
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
PMA/PMN Number
K171410
Number of Events Reported1
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
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
Initial Date Manufacturer Received 03/17/2023
Initial Date FDA Received03/22/2023
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 Number1
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