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

Model Number	02-01606
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Pain (1994); Electric Shock (2554)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 10 february 2024, that on (b)(6) 2024 the patient went to the emergency room (er) because they felt electric shocks under their armpit and towards the left side of their chest.The patient stated it felt like a teaser shock.The er ran tests such as an ekg (electrocardiography) and lab work.Everything was normal.The hospital staff noted that it could have been the heart monitor that could have caused the issue.The patient removed the device and has not had any issues since removing the device.
Additional Manufacturer Narrative
It was reported that the patient expereinced a electrical shock under their armpit.The device was returned for investigation.Engineering evaluation could not replicate the reported event of the patient feeling a shock.The sensor passed all testing and found to be working according to specifications.

• Brand Name: C6 MCOT PPM
• Common Device Name: C6 MCOT PPM
• 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: 18832869
• Report Number: 2133409-2024-00015
• Device Sequence Number: 18006664
• Product Code: DSI
• UDI-Device Identifier: B146C6D10
• UDI-Public: +B146C6D10
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/02/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/10/2024; Not provided
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/16/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male