MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MONITOR A13, VERIZON; MCOT MONITOR - A13 - VERIZON

Model Number	02-02118
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was report on 01 august 2024 on an unknown date that when the patient went to charge the c6 monitor, the c6 monitor charging cord overheated and melted.The patient reported that the monitor was still functioning.A new charging cord was offered but the patient declined and said they had a charger that worked.
Additional Manufacturer Narrative
It was reported that the c6 mcot monitor was charging and the mcot monitor charger overheated and melted.The c6 mcot monitor and mcot monitor charger was returned for device evaluation.Device was inspected for general physical integrity, found in good condition.Charging port does not appear to have been damaged.Charging cord was also returned and has evidence of the device melt.Engineering evaluation was able to confirm the melt event.During visual inspection the charging port was visibly burnt although there is no evidence that the monitor itself was the source of the melt.Charging cable - monitor - a to c.Am&d philips is further investigating this reported malfunction.

• Brand Name: C6 MONITOR A13, VERIZON
• Common Device Name: MCOT MONITOR - A13 - VERIZON
• 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: 20066489
• Report Number: 2133409-2024-00055
• Device Sequence Number: 8496440
• Product Code: DSI
• UDI-Device Identifier: B146C6M90
• UDI-Public: +B146C6M90
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 02-02118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: 26 YR
• Patient Sex: Female