MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 PATCH VERIZON; C6 MONITOR VERIZON

Model Number	02-01804
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the monitor charger and monitor itself was burnt and damaged.The devices returned for investigation.A capa has been initiated for mcot usb-a/ usb-c cables overheating failures.Although unit,c6m,a10e,u (b)(6), 02-01894 udi: (b)(4), was named in the allegation it has been identified that the charging cord is the source of this failure.
Event or Problem Description
The patient's daughter reported that monitor charger was burnt and damaged as well as the monitor itself.There were no reported injuries.The device was requested to be returned.

• Brand Name: C6 PATCH VERIZON
• Common Device Name: C6 MONITOR 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: 17641542
• Report Number: 2133409-2023-00048
• Device Sequence Number: 15448390
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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: 02-01804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CHARGE CORD, RED FOR A10E PHONE, 700-0770-01
• Patient Sex: Female