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

Model Number	02-02118
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, in the early morning the patient had plugged their mcot monitor into the charger to charge.About 15 minutes later the patient wnet back to check on the monitor and noticed it was hot to the touch.It appeared that the usb charging cord had melted into the monitor.The patient unplugged the monitor from the wall outlet and packed the kit up.A replacement kit was ordered.There was no property damage or patient injury reported.
Additional Manufacturer Narrative
It was reported that c6 monitor charging cord melted when charging the monitor.The c6 monitor was returned for investigation.Monitor was inspected for general physical integrity, was found to have damage at the charge port.Monitor was not functional to charge.No additional testing could be performed.Engineering evaluation was able to confirm the melt event.During visual inspection the charging port was visibly burnt although there is no evidence that the monitor itself as the source of the melt.Am&d philips is further investigating this reported allegation.

• Brand Name: C6 MCOT PPM
• Common Device Name: MCOT 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 drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 19264250
• Report Number: 2133409-2024-00029
• Device Sequence Number: 11408634
• Product Code: DSI
• UDI-Device Identifier: B146C6M50
• UDI-Public: +B146C6M50/$$+7MT31051483
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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 Model Number: 02-02118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHARGING CABLE - MONITOR - A TO C, 01-01970.
• Patient Age: 71 YR
• Patient Sex: Male