MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT

Model Number UNIT, J3 S 2018, C6M

Device Problem Patient Data Problem (3197)

Patient Problem Cardiac Arrest (1762)

Event Date 11/01/2019

Event Type  Death  

Event Description

Complainant alleged that the mcot system was not recording critical events and/or notifying his medical professionals of critical events.

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
• Type of Device: 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
• MDR Text Key: 287318016
• Report Number: 2133409-2022-00001
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6M50
• UDI-Public: B146C6M50
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNIT, J3 S 2018, C6M
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Sex: Male