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

Model Number 02-01894

Device Problems Moisture Damage (1405); Smoking (1585)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

The patient reported that the monitor was damaged due to a smoking charging cord.The patient reacted and threw water on the smoking charging code.The monitor no longer functions due to the water and charging port is damaged.The patient reported that she received a small brun.The patient did not require medical attention.The devcie was returned.

Manufacturer Narrative

It was reported that the monitor was damaged due to a smoking charging cord.The monitor no longer functioned.The monitor and the charging cord was returned for investigation.Engineering evaluation was able to confirm the reported complaint of "monitor damaged due to a smoking cord".The most likely root cause of the reported event is the due to an electrical fault within usb-a/usb-c charging cord.The component failure is further being investigated by philip's am&d.

• 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: 17885899
• MDR Text Key: 325084810
• Report Number: 2133409-2023-00060
• 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,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female