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

Model Number	02-01894
Medical Device Problem Codes	Melted (1385); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient plugged the monitor into the charger and took a shower.When the patient came out of the shower it was noted that the monitor charging cord was melted into the monitor and both were smoking.No patient harm was reported.A replacement monitor and charger was sent.
Additional Manufacturer Narrative
It was reported that the monitor caught fire when plugged into the chager.The device was not returned.Engineering evaluation was unable to performed as the device was not returned for testing.This failure mode description aligns with a known existing failure which is being investigated by philips 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 ; 6512968630
• MDR Report Key: 17980987
• Report Number: 2133409-2023-00066
• Device Sequence Number: 2504943
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70$$+7MT29119684N
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 03/12/2024; 07/08/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 03/15/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female