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

Model Number 02-02118

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

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

Event Date 11/21/2023

Event Type  malfunction  

Event 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.

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.

• 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: 18344479
• MDR Text Key: 330798667
• Report Number: 2133409-2023-00076
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6M90
• UDI-Public: B146C6M90
• 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: 03/15/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 02-02118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2023
• 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: 69 YR
• Patient Sex: Male