BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 818482 · Received December 21, 2006

    Report

    Report Number
    818482
    Event Type
    Malfunction
    Date Received
    December 21, 2006
    Date of Event
    August 11, 2006
    Report Date
    December 21, 2006
    Manufacturer
    LMA NORTH AMERICA, INC.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENGINEERING CALLED TO OR FOR ANESTHESIA MACHINE ALARMING. THERE APPEARED TO BE A MASSIVE AIRWAY PRESSURE LEAK. PATIENT WAS STABLE AND OXYGENATING FINE WITH ALL VITALS NORMAL. ANESTHESIA TECH SAID SHE HAD CHANGED THE SODA-LIME BEFORE THE CASE. NO OBVIOUS PROBLEMS WITH THE CANISTER, TUBING OR ABSORBER WERE FOUND. THE CASE WAS NEARLY COMPLETE. THE MACHINE WAS SWAPPED OUT AFTER THE CASE. THE CIRCUIT AND INTUBATION TUBE WERE SEQUESTERED. THE MACHINE OPERATION WAS VERIFIED IN SEVERAL MODES USING THE SUSPECT CIRCUIT TUBING. EVERYTHING LOOKED FINE, PASSED INSPECTIONS AND HELD PRESSURES. THE RECALLED HISTORY OF THE MACHINE SHOWED A PASSED PRESSURE CHECK WITH TIMING THAT COINCIDED WITH PRE-USE CHECK OUT. NOTE: THE INTUBATION TUBE INFLATED ON DRY RUN AND TEN MINUTES LATER WAS DOWN A BIT. IT IS NOT CLEAR AT THIS TIME WHAT LEAK RATE (IF ANY) IS ACCEPTABLE. THE INTUBATION TUBE WAS A NUMBER THREE LMA (LARYNGEAL MASK AIRWAY) CLASSIC MODEL. SUSPECT INTUBATION TUBE WAS NOT INFLATED JUST RIGHT AND LEAKAGE OCCURRED AROUND THE AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TUBE, ENDOTRACHEAL, LMA CAE LMA NORTH AMERICA, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *