BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2945337 · Received February 1, 2013

    Report

    Report Number
    2028159-2013-00111
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND DUPLICATED THE PROBLEM REPORTED. THE SUPERVISOR PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCTS SPECIFICATIONS. A SAMPLE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE HAS NOT YET BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SYSTEM MESSAGE DISPLAYED DURING A VITRECTOMY PROCEDURE. THE PATIENT'S EYE WAS STABILIZED AND THEY TRIED A "QUICK BOOT" WITHOUT SUCCESS. THE CUSTOMER CONTACTED TECHNICAL SERVICES AND WAS INSTRUCTED TO DO A COMPLETE REBOOT OF THE SYSTEM. THE SYSTEM REBOOTED SUCCESSFULLY AND THE CASE WAS ABLE TO BE COMPLETED FOLLOWING A DELAY OF GREATER THAN 15 MINUTES. THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER ALSO REPORTED THAT C3F8 GAS PRESSURE WOULD NOT GO ABOVE 150 PSI, THE SYSTEM WAS "REJECTING" CASSETTES DURING SET-UP, AND THAT IT WAS NOT RECOGNIZING WHEN THE BSS (BALANCED SALT SOLUTION) BOTTLE WAS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45301 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1