MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM; MCOT SENSOR

Model Number	02-01846
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 18 march 2024, that on (b)(6) 2024 the patient was plugging the dual usb charging plug into the wall outlet to charge the mcot sensor and mcot monitor.The dual usb charging plug broke and someone was shocked.The patient stated that they attempted to pull the charger out of the wall outlet and the prongs remained inside the wall outlet and their wife experienced a shock.No medical attention was sought.A replacement dual usb charging plug was ordered.
Additional Manufacturer Narrative
It was reported the wall charger - dual port charger was broken and the patient was shocked.The wall charger - dual port charger or mcot c6 sensor was returned for device evaluation.Evaluation was unable to be performed as the device was not returned or is unable to be recovered.

• Brand Name: C6 MCOT PPM
• Common Device Name: MCOT SENSOR
• 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 driv; suite 150; eagan, MN 55121
• MDR Report Key: 19020516
• Report Number: 2133409-2024-00023
• Device Sequence Number: 11731439
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: B146C6E10
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: MCOT MONITOR - A10E - VERIZON, 02-01804; WALL CHARGER - DUAL PORT CHARGER,01-02034
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male