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

Model Number 02-01800

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

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.

• Brand Name: C6 MCOT PPM
• Type of Device: 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
• MDR Text Key: 330797106
• Report Number: 2133409-2023-00079
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6M60
• UDI-Public: B146C6M60
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-01800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: USB CHARGING CORD - SENSOR V2.0 NO USB, 700-0770-0
• Patient Age: 83 YR
• Patient Sex: Male