BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON CONSTELLATION LXT

    MDR report key: 2613931 · Received June 5, 2012

    Report

    Report Number
    MW5025697
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Report Date
    June 5, 2012
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING CASE, GAS WAS BEING DRAWN UP AND A TOP SIGN APPEARED ON THE SCREEN OF THE CONSTELLATION LXT WITH TWO OPTIONS, "QUICK START" OR "SHUTDOWN." STAFF SELECTED "QUICK START." PHYSICIAN REMOVED INFUSION LINE FROM PATIENT'S EYE. VALVED CANNULAS IN EYE MAINTAINED THE PRESSURE IN PATIENT'S EYE UNTIL THE MACHINE REBOOTED. MACHINE TAGGED FOR REPAIR AND REPORTED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON CONSTELLATION LXT CONSTELLATION LXT HQC ALCON LABORATORIES CONSTELLATION LXT

    Patients

    Seq Age Sex Outcome Treatment
    1