BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FASTRACH ETT (SINGLE USE) 7.0MM/9.8MM OD

    MDR report key: 889403 · Received July 9, 2007

    Report

    Report Number
    889403
    Event Type
    Malfunction
    Date Received
    July 9, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 9, 2007
    Manufacturer
    LMA NORTH AMERICA, INC.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO PASS ENDOTRACHEAL TUBE THROUGH LMA (LARYNGEAL MASK AIRWAY), IT WOULD NOT PASS DUE TO BLOCKED/SMALL FLAP THAT WAS STUCK. LMA WAS REMOVED FROM PATIENT AND ANOTHER USED DURING PROCEDURE. MALFUNCTIONING FLAP THAT WOULD NOT ALLOW ET TUBE TO PASS WAS OPENED AFTER REMOVAL FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LMA FASTRACH ETT (SINGLE USE) 7.0MM/9.8MM OD INTUBATING AIRWAY SYSTEM CAE LMA NORTH AMERICA, INC. REF 136070 MN2805

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR