BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2913544 · Received December 21, 2012

    Report

    Report Number
    2028159-2012-02046
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND DISASSEMBLED, CLEANED, AND LUBRICATED THE IV POLE TO ADDRESS THE ISSUE. PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE 1 RELATED REPORT(S) FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SYSTEM MESSAGE DISPLAYED AND THE IV POLE WOULD NOT GO UP OR DOWN DURING A CATARACT PROCEDURE. THE CASE WAS COMPLETED USING THE SAME EQUIPMENT FOLLOWING A DELAY OF MORE THAN 15 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    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 UNK