BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRAY, SURGICAL, INSTRUMENT

    MDR report key: 10785849 · Received November 4, 2020

    Report

    Report Number
    10785849
    Event Type
    Death
    Date Received
    November 4, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 29, 2020
    Manufacturer
    HEINE USA LTD
    Product Code
    FSM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FROM STAFF: DOCTOR WAS INTUBATING THE PATIENT AND THE LIGHT ON THE LARYNGOSCOPE WAS FLICKERING AND KEPT GOING OUT. IT WAS DIFFICULT TO SEE AND HAD TO REINTUBATE TWICE. PATIENT HAD SLOWED HEART RATE ONCE INTUBATED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248455 TRAY, SURGICAL, INSTRUMENT FSM HEINE USA LTD F-001.22.860

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA Death