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

Model Number 02-01804

Device Problems Overheating of Device (1437); Difficult to Remove (1528)

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

Event Date 01/27/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024 the patient called reporting that charging cord is stuck in the monitor and the monitor was hot to the touch.The patient was instructed to power off the monitor and return it.A replacement was order.No harm to the patient was reported.

Manufacturer Narrative

It was reported that the monitor was hot to the touch and the charging cord was stuck in the monitor.The device as returned for investigation.Engineering evaluation was able to confirm or device overheating and melting.Device was inspected for general physical integrity, phone was in melted onto the charging cord.Philip's am&d are doing further investigation of this reported issue.

• 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: 18793573
• MDR Text Key: 337628181
• Report Number: 2133409-2024-00009
• 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?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CHARGE CORD, RED FOR A10E PHONE, 700-0770-01
• Patient Age: 84 YR
• Patient Sex: Male