BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2072379 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00359
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A NURSE REPORTED DURING SURGERY, THE IV POLE HAD TO BE REPLACED AND THE BALANCED SALT SOLUTION (BSS) CONTROL HAD TO BE PERFORMED MANUALLY. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A NURSE REPORTING THE SYSTEM DISPLAYED AN ERROR MESSAGE DURING A CATARACT PROCEDURE AND THE REMOTE CONTROL STOPPED WORKING. THE CUSTOMER VERIFIED, USING THE OPERATOR'S MANUAL, THE MEANING OF THE DISPLAYED SYSTEM MESSAGE AND FOUND THAT IT WAS RELATED TO THE IV POLE. ACCORDING TO THE MANUAL, THE IV POLE HAD TO BE REPLACED AND THE BSS CONTROL HAD TO BE PERFORMED MANUALLY. THE FACILITY FOLLOWED THOSE INSTRUCTIONS AND COMPLETED THE PROCEDURE AFTER A 40 MINUTE DELAY. THERE WAS NO PATIENT HARM 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