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

Model Number	02-01894
Medical Device Problem Codes	Moisture Damage (1405); Smoking (1585)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that the monitor was damaged due to a smoking charging cord.The patient reacted and threw water on the smoking charging code.The monitor no longer functions due to the water and charging port is damaged.The patient reported that she received a small brun.The patient did not require medical attention.The devcie was returned.
Additional Manufacturer Narrative
It was reported that the monitor was damaged due to a smoking charging cord.The monitor no longer functioned.The monitor and the charging cord was returned for investigation.Engineering evaluation was able to confirm the reported complaint of "monitor damaged due to a smoking cord".The most likely root cause of the reported event is the due to an electrical fault within usb-a/usb-c charging cord.The component failure is further being investigated by philip's am&d.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: C6 MCOT PPM
• Common Device Name: C6 MCOT PPM
• 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: 17885899
• Report Number: 2133409-2023-00060
• Device Sequence Number: 17867754
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 07/12/2024

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: 02-01894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 01/31/2024; 07/08/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 02/19/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 65 YR
• Patient Sex: Female