BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1832037 · Received September 3, 2010

    Report

    Report Number
    2028159-2010-01689
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Report Date
    August 4, 2010
    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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED SYSTEM MESSAGE. THE SOLENOID SPACERS WERE INSPECTED AND WERE FOUND TO BE INTACT. IT WAS NOTED THAT THE SHOULDER SCREW THAT ATTACHES THE VENT ARM TO THE FRAME WAS LOOSE. THIS SLOWED THE RETURN SPRING RESPONSE OF THE VALVE. THE SCREW WAS TIGHTENED AND THE SYSTEM MESSAGE CLEARED. PREVENTIVE MAINTENANCE WAS ALSO PERFORMED. THE SYSTEM WAS THEN TESTED AND THEN MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS AND SERVICE REQUESTS FOR THE LAST 24 MONTHS INDICATED NO ADDITIONAL, RELATED REPORTS FOR THIS SYSTEM. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INVOLVEMENT". PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A BIOMEDICAL ENGINEER REPORTED RECEIVING A SYSTEM MESSAGE DURING SETUP. THE SYSTEM WAS SWITCHED OUT AND ALL CASES WERE COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

    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