BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1840797 · Received September 17, 2010

    Report

    Report Number
    2028159-2010-01785
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FOOTSWITCH IS BEING SENT IN FOR IN HOUSE TESTING. 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 A PROBLEM WITH THE FOOTSWITCH. WHEN THE EQUIPMENT WAS TURNED ON A SYSTEM MESSAGE OCCURRED. THE PROCEDURE WAS COMPLETED USING A SECOND FOOTSWITCH. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1