BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1910048 · Received November 10, 2010

    Report

    Report Number
    2028159-2010-02164
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SYSTEM WAS TURNED ON AND FUNCTIONED FINE. THE COMPANY SERVICE REP ATTEMPTED TO DUPLICATE THE PROBLEM REPORTED AND FOUND THAT ANOTHER SYSTEM IS ALSO IN THE SAME ROOM. THE NURSE REMEMBERED SHE HAD PLACED SOME BOXES ON THE TOP OF THE OTHER SYSTEM ON TOP OF THE REMOTE CONTROL. THE REMOTE CONTROLS FOR BOTH SYSTEMS IN THE ROOM WERE BOTH ON THE SAME CHANNEL. IT APPEARS THIS TRIGGERED THE EPISODE WHERE THE SYSTEM WAS RUNNING ON ITS OWN. THE REMOTE CHANNELS WERE CHANGED TO DIFFERENT CHANNELS. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS NOT FUNCTIONING PROPERLY WHEN THE POWER WAS SWITCHED ON IN THE MORNING. THE TOUCH SCREEN DIDN'T RESPOND TO TOUCH, THE FOOTSWITCH DIDN¿T WORK, AND THE SYSTEM WAS MAKING A CLICKING SOUND. THE SYSTEM WOULD NOT PRIME. WHEN THE STAFF WAS ABLE TO GET THE SYSTEM SURGERY WINDOW OPEN, THE SYSTEM STARTED RUNNING FROM ONE MODE TO ANOTHER. THE MODES WERE RUNNING WITHOUT ANYONE ACTUALLY TOUCHING THE SCREEN, REMOTE, OR FOOTSWITCH. A YOUNG CHILD WAS TO BE OPERATING THAT MORNING PLUS ONE OTHER CHILD AND TWO ADULTS. THE FIRST CHILD WAS ALREADY ON THE OPERATING TABLE AND UNDER GENERAL ANESTHESIA. THE SURGERIES WERE CANCELLED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR