BEUDAMED
    FDA Adverse Event Other Summary report: N

    8.0MM HI LO W/LANZ

    MDR report key: 250407 · Received November 12, 1999

    Report

    Report Number
    9681384-1999-00038
    Event Type
    Other
    Date Received
    November 12, 1999
    Date of Event
    October 10, 1999
    Report Date
    November 11, 1999
    Manufacturer
    MMJ SA DE CV
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED: "INFLATION LINE ON HI-LO LANZ SEPARATED FROM PILOT VALVE/BALLO. VENTILATOR WAS ALARMING AND CLINICIANS RUSHED INTO ROOM ONLY TO FIND THE LANZ/CUFF PRESSURE REGULATING VALVE/BALLOON LAYING ON THE BED DISCONNECTED FROM THE ET TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.0MM HI LO W/LANZ ENDOTRACHEAL TUBE BTR MMJ SA DE CV NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other