BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH

    MDR report key: 8067312 · Received November 13, 2018

    Report

    Report Number
    3010244187-2018-00003
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    November 1, 2016
    Report Date
    November 13, 2018
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CAL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE RANDOMIZED TRIAL OF VIDEO LARYNGOSCOPY FOR ENDOTRACHEAL INTUBATION OF CRITICALLY ILL ADULTS SOURCE CLINICAL INVESTIGATIONS. 11 (1980-1987), NOVEMBER 2016. ARTICLE NUMBER: 44. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, THE DEVICE WAS USED AND WAS UNABLE TO INTUBATE PATIENT ON FIRST ATTEMPT DUE TO POOR CAMERA IMAGE HENCE INABILITY TO PASS AN ENDOTRACHEAL TUBE INTO THE TRACHEA. IT WAS REPORTED THAT THERE WERE PROCEDURAL COMPLICATIONS SUCH AS ASPIRATION, ESOPHAGEAL INTUBATION, HYPOTENSION, HYPOXIA, CARDIAC ARREST AND AIRWAY TRAUMA. AUTHOR: DAVID R. JANZ, MD, 2016, THE SOCIETY OF CRITICAL CARE MEDICINE AND WOLTERS KLUWER HEALTH, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905847 MCGRATH LARYNGOSCOPE, NON-RIGID CAL AIRCRAFT MEDICAL LIMITED 500-000-000-

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other