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

Model Number	02-02119
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 15 july 2024 the c6 monitor charger seem to melted in the monitor.A replacement was ordered.No injuries were reported.Additional information was requested but could not be obtained.
Additional Manufacturer Narrative
It was reported that the c6 monitor charger melted into the monitor.The device was returned for investigation.He 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 through to the inside cavity.A visual inspection of the usb-c cable also identified a melted cable, indicative of thermal damage.No further functional test of the monitor was performed due to the extent of damage to the charging port.Engineering evaluation was able to confirm the reported event of "monitor seems to be melted into charger".There was clear evidence of heat damage to both the usb-c charging cable and the charging port of the a13 monitor.The most likely root cause is an electrical fault within the usb-c cable, allowing excess current to flow through to the monitor.Am&d philips is further investigating this known allegation.

• 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: 19783504
• Report Number: 2133409-2024-00042
• Device Sequence Number: 8068477
• 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): 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: 02-02119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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: 31 YR
• Patient Sex: Female