BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH

    MDR report key: 9180594 · Received October 11, 2019

    Report

    Report Number
    3010244187-2019-00018
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    January 24, 2017
    Report Date
    October 11, 2019
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVERSE EVENT WITHOUT IDENTIFIED DEVICE TITLE VIDEO LARYNGOSCOPY VS DIRECT LARYNGOSCOPY ON SUCCESSFUL FIRST-PASS OROTRACHEAL INTUBATION AMONG ICU PATIENTS A RANDOMIZED CLINICAL TRIAL SOURCE EFFECTS OF VIDEO VS DIRECT LARYNGOSCOPY ON SUCCESSFUL OROTRACHEAL INTUBATION IN ICU PATIENTS, VOLUME 317, 2017 (483-493) ARTICLE NUMBER: 5 DATE OF PUBLICATION ONLINE: JANUARY 24, 2017. 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 TO DETERMINE IF ROUTINE USE FOR OROTRACHEAL INTUBATION OF PATIENTS IN THE INTENSIVE CARE UNIT (ICU) INCREASED THE FREQUENCY OF SUCCESSFUL FIRST-PASS INTUBATION COMPARED WITH USE OF THE MACINTOSH DIRECT LARYNGOSCOPE. OUT OF 186 PATIENTS IN THE GROUP, 4 PATIENTS THAT EXPERIENCED A CARDIAC ARREST, 3 PATIENTS THAT EXPERIENCED AN ARRHYTHMIA, 3 PATIENTS IN WHICH AN ESOPHAGEAL INTUBATION OCCURRED, 4 PATIENTS THAT EXPERIENCED ASPIRATION, 14 PATIENTS WITH HYPOXEMIA, 6 PATIENTS WITH SEVERE HYPOXEMIA, AND 8 PATIENTS WITH HYPOTENSION. ALL BUT 2 PATIENTS WERE INTUBATED. IT WAS UNCLEAR WHETHER ALL COMPLICATIONS WERE DIRECTLY RELATED TO THE DEVICE OR DUE TO PATIENT STATUS AT THE TIME OF INTUBATION/OTHER COMORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975299 MCGRATH LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R