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

Model Number	02-01800
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when the patient's wife called and stated that the c6 monitor charging cord is not working.The charging cable got hot and melted and the the patient can no longer charger the c6 monitor.A replacement charger was ordered.The patient later called stating they would no longer like to continue with service and will return the replacment device.No patient injury or harm was reported.
Additional Manufacturer Narrative
It was reported that the charging cord for the monitor was not working.The cable got hot and melted.The device was scrapped.Engineering evaluation was unable to be performed.Therefore it is most probable that the monitor did not cause or contribute to this event, although this reported failure mode aligns with a know failure mode that is further 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: 18344783
• Report Number: 2133409-2023-00079
• Device Sequence Number: 5341875
• Product Code: DSI
• UDI-Device Identifier: B146C6M80
• UDI-Public: +B146C6M80/$$+7MT30002032
• 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: 02-01800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 03/20/2024; 07/08/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/28/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: USB CHARGING CORD - SENSOR V2.0 NO USB, 700-0770-0
• Patient Age: 83 YR
• Patient Sex: Male