BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1960415 · Received December 16, 2010

    Report

    Report Number
    2028159-2010-02360
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 16, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTS THAT WHILE THE SYSTEM WAS PERFORMING THE INITIAL BOOT-UP SEQUENCE, THE NURSE UNPLUGGED THE SYSTEM TO MOVE IT AGAINST THE OTHER WALL. THE SYSTEM IMMEDIATELY DISPLAYED AN "INACCESSIBLE BOOT DEVICE" MESSAGE AND WOULD NOT ALLOW FOR REBOOT. THERE WAS NO BACKUP SYSTEM AVAILABLE AND 2 CASE WERE ALREADY PREPPED FOR SURGERY. ALL CASES WERE DELAYED BETWEEN 2 AND 2.5 HOURS BEFORE THE SISTER FACILITY WAS ABLE TO PROVIDE A SECONDARY UNIT TO COMPLETE THE CASES FOR THE DAY. NO PATIENT HARM 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