BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1022945 · Received March 28, 2008

    Report

    Report Number
    2028159-2008-00121
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE COMPLAINT. THE HOST MODULE WAS REPLACED AND SENT IN FOR HOUSE EVALUATION. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSRY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED. THE SYSTEM WAS NOT 'BOOTING' PROPERLY. THE CUSTOMER STATED THERE WAS A DELAY, BECAUSE THEY HAD TO MOVE ONE SYSTEM BACK AND FORTH BETWEEN OPERATING ROOMS. ONE CASE WAS DELAYED AT LEAST 2 HOURS AND THE OTHERS WERE DELAYED ONLY BY MINS. NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI