BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1843353 · Received September 22, 2010

    Report

    Report Number
    2028159-2010-01797
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT CONFIRM THE PROBLEM REPORTED. THE CASSETTE ID PCB WAS REPLACED FOR DIAGNOSTIC PURPOSES. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS NOT ACCEPTING CASSETTES. A SYSTEM MESSAGE DISPLAYED. THE EVENT OCCURRED DURING THE SET UP PROCESS. THE PT WAS IN THE ROOM PREPPED AND DRAPED. THE CASSETTE WAS SWITCHED OUT 2 OR 3 TIMES. THE SYSTEM WAS REBOOTED WITH NO CHANGE. THE SYSTEM WAS SWITCHED OUT AND THE CASE PROCEEDED. THE CASE WAS COMPLETED AS PLANNED. THERE WAS A 15 MINUTES DELAY. NO PT INJURY WAS 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 UNK