BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1083234 · Received July 24, 2008

    Report

    Report Number
    2028159-2008-00271
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH SUPPORT REP HAD THE CUSTOMER RESEAT THE CABLE AND REBOOTED THE SYSTEM. UNIT FUNCTIONS ARE NORMAL, CUSTOMER COMPLETED CASES WITHOUT FURTHER PROBLEMS, BUT STILL WANTED THE SYSTEM CHECKED OUT. A COMPANY SERVICE REP CHECKED THE SYSTEM, OBSERVED THE ERROR IN ERROR LOG, BUT COULD NOT REPEAT THE ERROR. THE CABLE WAS REPLACED FOR DIAGNOSTIC PURPOSES, AND WAS RETURNED FOR FURTHER EVALUATION. THE REP COMPLETED THE PM CHECKLIST, AND THE SYSTEM MET SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED, WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT AN ERROR CODE (401) CAME UP AND COULD NOT BE CLEARED. THE SYSTEM WAS REBOOTED MULTIPLE TIMES WITH NO SUCCESS. THE TUBING WAS CLAMPED TO PREVENT THE EYE FROM BECOMING SOFT WHILE THEY TRIED TO GET ANOTHER MACHINE FROM A NEIGHBORING FACILITY. DURING THAT TIME, THEY SPOKE WITH A TECH SERVICE REP AND THEIR BIOMED, AND WERE TALKED THROUGH THE FIX (THEY HAD TO TAKE A BACK PANEL OFF, ETC). CASE WAS DELAYED ONE HOUR. A SYSTEM WAS BORROWED FROM ANOTHER FACILITY TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS OPHTHALMIC SURGERY SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 800CS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR