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

Model Number	02-02119
Medical Device Problem Codes	Melted (1385); Device Emits Odor (1425); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024 the patient's father noted that the mcot monitor was charging on and it was noted that something smelt like it was burning.The patient's father realized that mcot monitor charger was melted inside of the monitor.No injuries were reported.A replacement kit was sent.
Additional Manufacturer Narrative
It was reported that the patient was charging the c6 mcot monitor and the patient started to smell something burning and it was noted that the charger was melted inside the monitor.The device was returned for investigation.Engineering evaluation was able to confirm the burn event.During visual inspection the charging port was visibly burnt although there is no evidence that the monitor itself was the source of the burn.Overheating and melting of the charge cable is a known product defect and is being further being investigated by philips am&d.

• Brand Name: C6 MCOT PPM
• Common Device Name: MCOT 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: 19249038
• Report Number: 2133409-2024-00028
• Device Sequence Number: 7332662
• Product Code: DSI
• UDI-Device Identifier: B146C6M80
• UDI-Public: +B146C6M80/$$7MT30008665E
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 02-02119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/23/2024; Not provided
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/01/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHARGING CABLE - MONITOR - A TO C, 01-01970
• Patient Age: 16 YR
• Patient Sex: Male