BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1832038 · Received September 3, 2010

    Report

    Report Number
    2028159-2010-01687
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 4, 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
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. HOWEVER, THE SYSTEM MESSAGE WAS VERIFIED IN THE EVENT LOG. THE FLUIDICS MODULE WAS REPLACED FOR EVALUATION PURPOSES AND WAS RETURNED FOR IN-HOUSE TESTING. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE REPLACED FLUIDICS MODULE HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A NURSE REPORTED RECEIVING A SYSTEM MESSAGE DURING SETUP. THE MESSAGE WAS CLEARED, THE CASE WAS STARTED, THEN THE SYSTEM MESSAGE WAS DISPLAYED AGAIN. THE SYSTEM WAS REBOOTED, THE MESSAGE WAS CLEARED, AND THE CASE WAS COMPLETED. THERE WAS A 2 MINUTE DELAY. THERE WAS NO PATIENT INJURY 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