BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1791435 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01424
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. ALL THE CONNECTIONS WERE CHECKED AND THE CARDS WERE RESEATED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INVOLVEMENT" (NO PATIENT INVOLVEMENT). PRODUCT PROBLEM(S): "SYSTEM SHUT DOWN" (OPERATING SYSTEM BECOMES NON-FUNCTIONAL). A FACILITY REPORTED THE UNIT SHUT DOWN ON ITS OWN AFTER THE LAST CASE WAS COMPLETED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1