BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 8128128 · Received December 4, 2018

    Report

    Report Number
    8128128
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    September 3, 2018
    Report Date
    November 20, 2018
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INDUCTION OF ANESTHESIA THE MCGRATH SCREEN KEPT FLICKERING ON AND OFF. ANOTHER MCGRATH WAS OBTAINED, HOWEVER, MD WAS ABLE TO INTUBATE WITHOUT INCIDENT WITH REGULAR LARYNGOSCOPE AND BLADE. INSTRUMENT WAS TAKEN OUT OF SERVICE FOR REPAIR. THE POTENTIAL FOR SERIOUS COMPLICATIONS COULD HAVE BEEN GREATER IF THE MD WAS UNABLE TO INTUBATE WHILE ANOTHER MCGRATH WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968500 MCGRATH LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1