MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MONITOR A13, VERIZON; MCOT MONITOR - A13 - VERIZON

Model Number	02-02118
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 09 july 2024, that the monitor was hot.The c6 monitor was charging and the charging cord became hot.The monitor itself was warm and would not power off.The monitor displayed a message about high temperature.The patient attempted to power off the monitor but was unable to do so.The patient also reported that the monitor and charging cord cause property damage however did not elaborate what was damaged however, the patient did report that the they were burnt due to the overheating monitor and charging cord.The patient did not require medical treatment for the burnt finger.A replacement was order.Additional information was requested but was unsucessful.
Additional Manufacturer Narrative
It was reported that the mcot monitor was hot and the mcot monitor charging cord became hot.The mcot monitor was returned for device evaluation.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 was the source of the melt.Philip's am&d is further investigating this known malfunction.

• Brand Name: C6 MONITOR A13, VERIZON
• Common Device Name: MCOT MONITOR - A13 - VERIZON
• 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: 19934206
• Report Number: 2133409-2024-00046
• Device Sequence Number: 2847093
• Product Code: DSI
• UDI-Device Identifier: B146C6M90
• UDI-Public: +B146C6M90
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: 02-02118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: 68 YR
• Patient Sex: Female