BEUDAMED
    FDA Adverse Event Death Summary report: N

    C6 MCOT

    MDR report key: 13792950 · Received March 17, 2022

    Report

    Report Number
    2133409-2022-00001
    Event Type
    Death
    Date Received
    March 17, 2022
    Date of Event
    November 1, 2019
    Report Date
    March 16, 2022
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146C6M50
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT THE MCOT SYSTEM WAS NOT RECORDING CRITICAL EVENTS AND/OR NOTIFYING HIS MEDICAL PROFESSIONALS OF CRITICAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766070 C6 MCOT C6 MCOT DSI BRAEMAR MANUFACTURING, LLC UNIT, J3 S 2018, C6M B146C6M50

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death