BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1854328 · Received September 30, 2010

    Report

    Report Number
    2028159-2010-01866
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PT'S GENDER: UNK. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE FLUIDICS MODULE WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE FLUIDICS MODULE HAS 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 IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT DURING PRIMING, ON THE FIRST CASE, A SYSTEM MESSAGE DISPLAYED. THE CASSETTE WAS SWITCHED OUT AND THE SYSTEM MESSAGE CLEARED. ON THE SECOND CASE THE SYSTEM MESSAGE DISPLAYED AGAIN. THE CASSETTE WAS SWITCHED OUT THREE TIMES AND THE SYSTEM MESSAGE WOULD NOT CLEAR. THE SYSTEM WAS SWITCHED OUT AND THE CASE PROCEEDED. A 50 MINUTE DELAY WAS EXPERIENCED BETWEEN THE FIRST TWO CASES. THE FACILITY USUALLY RUNS THREE ROOMS WITH THREE SYSTEMS. THEY CONTINUED TO RUN THREE ROOMS. HOWEVER, BEING DOWN TO TWO SYSTEMS, THE STAFF HAS TO SWITCH ONE SYSTEM BETWEEN TWO ROOMS. HOWEVER, BEING DOWN TO TWO SYSTEMS, THE STAFF HAS TO SWITCH ONE SYSTEM BETWEEN TWO ROOMS. THIS CAUSED A DELAY AS THE DAY PROGRESSED. THE LAST 2 OF THE 15 CASES WERE CANCELLED.

    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