BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1840065 · Received September 15, 2010

    Report

    Report Number
    2028159-2010-01747
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ORDERED A NEW FOOTSWITCH. THE FOOTSWITCH AND CABLE HAVE BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE NURSE REPORTED A SYSTEM MESSAGE DISPLAYED DURING SET UP. THE SYSTEM MESSAGE NOTED A FOOTSWITCH FAILURE. ADDITIONAL INFO RECEIVED FROM THE NURSE STATED ONE CASE WAS DELAYED ABOUT 45 MINUTES. THE FACILITY WAS USING ONE OPERATING ROOM, INSTEAD OF TWO FOR A SHORT TIME. 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