BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 1022947 · Received March 28, 2008

    Report

    Report Number
    2028159-2008-00117
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND REPLACED THE PCB. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE PCB WAS SENT IN HOUSE FOR TESTING. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY WERE UNABLE TO CLEAR A TUNING MESSAGE DURING SET UP. NO PT INJURY WAS REPORTED, BUT THE CASE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI