BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA UNIQUE

    MDR report key: 2024178 · Received March 16, 2011

    Report

    Report Number
    2024178
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 16, 2011
    Manufacturer
    THE LARYNGEAL MASK COMPANY LIMITED
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    PT EXHIBITED RESPIRATORY CHANGES AND BRONCHOSPASM. UPON EXTUBATION, WE FOUND THE BALLOON ON THE LMA LARYNGEAL MASK AIRWAY TO BE DEFECTIVE AS IT FAILED TO REMAIN INFLATED. IT IS A STANDARD PROTOCOL AT OUR FACILITY TO PERFORM A LEAK TEST PRIOR TO USE. HOWEVER, THE LMA HAD BEEN IN USE FOR APPROX 30 MIN FOR THE DURATION OF THE SURGERY PRIOR TO NOTING THE BALLOON FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LMA UNIQUE LARNGEAL MASK AIRWAY CAE THE LARYNGEAL MASK COMPANY LIMITED * EEBEYB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR