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

Model Number 02-01894

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

Patient Problems Superficial (First Degree) Burn (2685); Blister (4537)

Event Date 01/27/2024

Event Type  malfunction  

Event Description

It was reported by that the patient's wife smelled something burning and went into the room where the c6 monitor was plugged in and charging.The wife noted that the c6 monitor cord was burn and the monitor was not responding.The patient's wife went to unplug the monitor was burnt on her finger and resulted in a small blister.The blister was "nothing' serious and did not require medical treatement.The patient paused in service and a replacement device was sent.

Manufacturer Narrative

It was reported the mcot monitor was plugged and when the patient's wife went into the room where the device was charging the charging cord was melted and it smelt like something was burning.The monitor was returned for investigation but not the charging cord.Engineering evaluation could not be performed on charging cable as charging cable - monitor - a to c was not returned.Allegation was confirmed via visual inspection of the monitor and the charging cable failure mode is a known issue and philips am&d is further investigating.

• Brand Name: C6 MCOT PPM
• Type of Device: 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: 18790172
• MDR Text Key: 337549782
• Report Number: 2133409-2024-00008
• Device Sequence Number: 1
• Product Code: DSI
• 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
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-01894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male