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

Model Number	+B14602-02119
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the c6 mcot monitor melted and became hot when plugged into the charging cord.The device was returned for investigation.Device was inspected for general physical integrity, was found to have damage at the charge port.Charging cord was also returned and has evidence of the device melt.The monitor is not likely the root cause of this allegation.Philips am&d is further investigation this reported issue overheating and melting of the charging cord.
Event or Problem Description
It was reported on 19 june 2024 that the c6 mcot monitor overheated and melted the charging cord.There was no allegation of burns or the patient being exposed to heat.The patient did report that the charging cord itself was very hot and where the cord connected into the outlet appeared to be burnt.The patient was directed to return the device and a replacement was ordered.

• Brand Name: C6 MONITOR A13, T MOBILE
• Common Device Name: MCOT MONITOR - A13 - T-MOBILE
• 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: 19783327
• Report Number: 2133409-2024-00043
• Device Sequence Number: 15481485
• Product Code: DSI
• UDI-Device Identifier: B146C6M80
• UDI-Public: +B146C6M80
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2024

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: +B14602-02119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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, (B)(6).
• Patient Age: 59 YR
• Patient Sex: Female