MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT

Model Number	UNIT, J3 S 2018, C6M
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/01/2019
Type of Reportable Event	Death
Event or Problem Description
Complainant alleged that the mcot system was not recording critical events and/or notifying his medical professionals of critical events.
Additional Manufacturer Narrative
Evaluation of the device indicates that there was no malfunction or deficiency of the device at the time of usage.Retrospective analysis shows the device continued to function as intended past the event of the allegation although prior to biotel hearts knowledge of the allegation.

• Brand Name: C6 MCOT
• Common Device Name: C6 MCOT
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 56121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 13792950
• Report Number: 2133409-2022-00001
• Device Sequence Number: 19789328
• Product Code: DSI
• UDI-Device Identifier: B146C6M50
• UDI-Public: B146C6M50
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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: UNIT, J3 S 2018, C6M
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/17/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 49 YR
• Patient Sex: Male