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

Model Number 02-02118

Device Problems Melted (1385); Temperature Problem (3022)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported that the patient's daughter called and stated that c6 monitor charging port had melted and the monitor is no longer working.The device was returned and a replacement was not sent.There was no report of patient harm or injury.

Manufacturer Narrative

It was reported the monitor charging port was melted and the monitor was not working.The monitor and charger cord was returned for investigation.Bom: 02-02118, product model: unit, c6m, a13, v, serial number: (b)(6) is not likely the root cause of this allegation.Product information updated to charge cord, red for a10e phone.Overheating and melting of the charge cable is a known product defect and philip's am&d is doing 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: 18039410
• MDR Text Key: 326971693
• Report Number: 2133409-2023-00065
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male