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

Model Number 02-01846

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 03/12/2024

Event Type  Injury  

Event 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.

• Brand Name: C6 MCOT PPM
• Type of Device: 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
• MDR Text Key: 339123793
• Report Number: 2133409-2024-00023
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: B146C6E10
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/02/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MCOT MONITOR - A10E - VERIZON, 02-01804; WALL CHARGER - DUAL PORT CHARGER,01-02034
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Male