BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1823640 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01611
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE FLUIDICS CONTROLLER PCB AND LOAD CELL WERE REPLACED. THE SOFTWARE WAS RELOADED. THE PARTS WILL BE RETURNING FOR IN-HOUSE EVAL. 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

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM WOULD NOT PRIME" (FAILURE TO PRIME); "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE NURSE REPORTED A SYSTEM MESSAGE DISPLAYED DURING SET UP. THE SYSTEM WOULD NOT PRIME. THE NURSE COULD NOT CLEAR THE SYSTEM MESSAGE. A LOANER SYSTEM WAS RETRIEVED AND THE CASES PROCEEDED. THERE WAS AN HOUR AND A HALF DELAY TO BEGIN SURGERY. NO PTS HAD BEEN BLOCKED, SEDATED, OR IMPACTED; THERE WERE NO CANCELLATIONS. 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 CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK