BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 1022946 · Received March 28, 2008

    Report

    Report Number
    2028159-2008-00122
    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
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT PRIME AND THEY RECEIVED AN ERROR MESSAGE "CHECK FITTINGS". THE EVENT OCCURRED DURING SET UP, WITH NO PTS IN THE OPERATING ROOM OR PREPPED FOR SURGERY. THE CUSTOMER DID CANCEL SEVEN CASES SINCE THEY DIDN'T HAVE A BACK UP SYSTEM.

    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