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

Model Number	02-02118
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023 the patient went to plug the c6 monitor in to recharge.The patient left while the monitor was charging.The patient returned and the cord was laying on the countertop and the patient noted that the charger was charred.The patient wanted to end service and return the kit however the patient's physician wanted the patient to continue.The device was returned and a replacement device was sent.No patient harm was reported.
Additional Manufacturer Narrative
It was reported the monitor charging cord was damaged and appeared burned.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 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: 18344479
• Report Number: 2133409-2023-00076
• Device Sequence Number: 15008088
• Product Code: DSI
• UDI-Device Identifier: B146C6M90
• UDI-Public: +B146C6M90/$$+7MT310227459
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/15/2024

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: Lay User/Patient
• Device Model Number: 02-02118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 03/13/2024; 07/08/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/15/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: USB CHARGING CORD - SENSOR V2.0 NO USB, 700-0770-0
• Patient Age: 69 YR
• Patient Sex: Male