BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1030934 · Received April 17, 2008

    Report

    Report Number
    2028159-2008-00136
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 18, 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE SYSTEM FROZE WITH AN ERROR MESSAGE. THE SYSTEM WAS RECONFIGURED AND A SOFTWARE UPGRADE WAS COMPLETED. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE ROOT CAUSE MAY HAVE BEEN CORRUPTED SOFTWARE AS THE SYSTEM WAS VERIFIED TO BE WITHIN SPECIFICATIONS AFTER THE CONFIGURATION AND SOFTWARE UPGRADE. A REVIEW OF THE COMPLAINT AND SERVICE REQUESTS FOR THE SYSTEM INDICATES THAT THERE HAVE BEEN NO ADDITIONAL COMPLAINTS OR SERVICE REQUESTS RELATED TO THE REPORTED EVENT. A TREND REVIEW OF THE COMPLAINT INDICATES THAT THERE HAS BEEN NO RECENT ADVERSE TRENDING OBSERVED IN THE LAST 36 MONTHS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TIP WAS IN THE PATIENT'S EYE WHEN THE UNIT SHUT DOWN. A BACK UP UNIT FROM THEIR SISTER HOSPITAL WAS NEEDED TO FINISH THE CASE. THERE WAS A TWO HOUR DELAY. THE SURGEON STATED THERE WAS NO UNPLANNED SURGICAL/MEDICAL INTERVENTION REQUIRED OR HOSPITALIZATION FOR THE PT. THE SURGEON STATED THE PT OUTCOME WAS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1