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

Model Number 02-01804

Device Problems Melted (1385); Overheating of Device (1437); Activation Failure (3270)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

It was reported that on 02 november 2023, that the patient noted that monitor was not working.The monitor kept shutting down from overheating and was stuck circling on the biotel screen.A replacement was ordered.The monitor was returned for investigation and the monitor charging cord was melted into the monitor charging port.

• 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: 18847871
• MDR Text Key: 337447502
• Report Number: 2133409-2024-00017
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: B146C6M70
• 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: 03/06/2024

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: 02-01804
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CHARGE CORD, RED FOR A10E (B)(6).
• Patient Age: 73 YR
• Patient Sex: Female