BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1231128 · Received November 12, 2008

    Report

    Report Number
    2028159-2008-00407
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE SYSTEM MESSAGE. THE FLUIDICS MODULE WAS REPLACED AND SENT FOR IN-HOUSE TESTING. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED, WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT A SYSTEM MESSAGE DISPLAYED DURING SET UP. THE COMPANY TECHNICAL SUPPORT SPECIALIST ASSISTED WITH TROUBLESHOOTING, WITH THE SYSTEM MESSAGE CONTINUING AFTER CHANGING CASSETTES. THE NURSE WAS UNABLE TO CLEAR THE SYSTEM MESSAGE, WITH NO VACUUM AVAILABLE. THREE CASES WERE CANCELLED AND RESCHEDULED. NO CONSUMABLES WERE SAVED FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI