BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2180964 · Received July 7, 2011

    Report

    Report Number
    2028159-2011-00767
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND DUPLICATED THE SYSTEM MESSAGE REPORTED. THE COMPANY REP RESEATED THE COMMUNICATION AND HOST CABLES. THE SYSTEM THEN BOOTED UP WITHOUT ANY ISSUES. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE WAS THAT THE COMMUNICATION AND HOST CABLES WERE NO PROPERLY SEATED. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED A SYSTEM MESSAGE WAS DISPLAYED, IN THE MIDDLE OF A CASE, AND WAS UNABLE TO BE CLEARED, AFTER A DELAY OF 20 MINUTES, THE SURGEON USED A BACK-UP SYSTEM TO COMPLETE THE CASE. THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1