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	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that c6 monitor charging cord melted and burned the patient's fiancée on (b)(6) 2024.It was reported that the patient's fiancée was burned by the melted plastic on the monitor charging unit on the their pointer finger.Medical treatment was not sought.The device was returned and replacement was order.
Additional Manufacturer Narrative
It was reported that the mcot monitor charging cord melted and was very hot and burned the patient's fiancée.The mcot monitor and charging cord was returned for device evaluation.Device was inspected for general physical integrity, was found to have damage at the charge port.Charging cord was also returned and has evidence of the device melt.Device 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.Philips am&d are further investigating this reported 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: 19972803
• Report Number: 2133409-2024-00048
• Device Sequence Number: 20573896
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 02-02118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHARGING CABLE - MONITOR - A TO C, 01-01970
• Patient Age: 56 YR
• Patient Sex: Male