BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLIGN

    MDR report key: 34859 · Received July 9, 1996

    Report

    Report Number
    34859
    Event Type
    Malfunction
    Date Received
    July 9, 1996
    Date of Event
    June 15, 1996
    Report Date
    July 8, 1996
    Manufacturer
    WELCH ALLYN
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INTUBATION LARYNGOSCOPE BLADE DISENGAGED FROM HANDLE. PIVOTAL ROLLER WAS WEDGED IN BLADE, PIVOTED PIN WAS MISSING. UNABLE TO FIND. X-RAY WAS NEGATIVE FOR FOREIGN BLADE. ON CONSULT WITH CO QA TECHNICAL SVC THE "SET SCREW WAS MISSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELCH ALLIGN LARYNGOSCOPE HANDLE EQN WELCH ALLYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other