BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1891062 · Received October 29, 2010

    Report

    Report Number
    2028159-2010-02096
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE REPRESENTATIVE DID DETECT A VERY SLIGHT BURNT SMELL FROM THE COMPUTER FAN, BUT THERE DID NOT APPEAR TO BE ANYTHING OBVIOUSLY BURNT IN THE HOST COMPUTER. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED AN ELECTRICAL ODOR COMING OUT FROM THE BACK OF THE UNIT DURING A CASE. THE ODOR WAS NOTICED AT THE BEGINNING OF THE DAY WHICH DELAYED THE START OF CASES FOR ABOUT 5-10 MINUTES AS TROUBLESHOOTING WAS BEING PERFORMED. THE SYSTEM WAS USED FOR THE REMAINDER OF THE DAY WITH NO OTHER ISSUES. THERE WAS NO PATIENT IMPACT 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