MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MONITOR A10E, VERIZON; MCOT MONITOR - A10E - VERIZON-UNLOCKED

Model Number	02-01894
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 10 june 2024, that the mcot c6 monitor charging cord melted and was hot to the touch while charging the monitor.There were no injuries reported.The patient discontinued service a day early and returned the device.
Additional Manufacturer Narrative
It was reported that the c6 monitor charging cord was hot to the touch and melted.The devcie was returned for investigation.The monitor was inspected for general physical integrity and a melted charge port was identified.Melted residue from the usb-c charging cable was observed around the mouth of the port.No further functional test of the monitor was performed due to the extent of damage to the charging port.Further engineering evaluation could not be performed as the usb-c charging cord was not returned.Engineering evaluation was able to confirm the reported event of "monitor cord was melting and hot to the touch".There was clear evidence of heat damage to the charging port of the a10e monitor with melted cable residue.The most likely root cause is an electrical fault within the usb-c cable, allowing excess current to flow through to the monitor, resulting in a melted cable and charge port.This is a known failure mode and am&d philips is further investigating.

• Brand Name: C6 MONITOR A10E, VERIZON
• Common Device Name: MCOT MONITOR - A10E - VERIZON-UNLOCKED
• 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: 19807518
• Report Number: 2133409-2024-00044
• Device Sequence Number: 17988709
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: +B146C6M70
• 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): 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): 08/26/2024

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: 02-01894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2022
• 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: 76 YR
• Patient Sex: Female