BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1003407 · Received February 21, 2008

    Report

    Report Number
    2028159-2008-00068
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TERRITORY MANAGER EXAMINED THE SYSTEM, BUT COULD NOT DUPLICATE THE REPORTED PROBLEM. THE ERROR CODE WAS FOUND IN THE EVENT LOG. THE POWER SUPPLY AND CPU BATTERY WERE REPLACED. THE POWER SUPPLY WAS SENT IN HOUSE FOR EVAL. THE RESISTANCE WAS MEASURED ACROSS THE FUSES AND IT PASSED. THE POWER SUPPLY WAS TESTED AND THE +24 VDC WAS BELOW SPECIFICATION. THE POWER SUPPLY WAS INSTALLED INTO THE HOT BED TESTER. NO ERROR CODES WERE DISPLAYED UPON POWER UP. A POSTERIOR CASSETTE WAS PRIMED AND A 2500 PROBE WAS USED FOR TESTING WITH NO ERROR CODES DISPLAYED. THE CONSOLE WAS LEFT ON FOR TWO HOURS AND NO ERROR CODES WERE DISPLAYED THROUGHOUT THAT TIME. ALTHOUGH THE ERROR CODE WAS NOT DISPLAYED ON THE CONSOLE, THE ROOT CAUSE FOR THE CUSTOMER'S REPORTED EVENT WAS DUE TO THE POWER SUPPLY HAVING THE +24 VDC VOLTAGE BE OUT OF SPECIFICATION. A REVIEW OF COMPLAINT TREND INDICATES NO ADVERSE TRENDS FOR THE REPORTED COMPLAINT RELATED TO THE ERROR CODE FOR THE LAST 36 MONTHS, ALTHOUGH THE ERROR CODE HAS SHOWN A SLIGHT INCREASE IN 2007 AND 2008. A REVIEW OF SERVICE DATA DETERMINED SYMPTOM CODE HAS NO ADVERSE TRENDS OVER THE LAST 36 MONTHS. THIS REPORT MAILED IN TO FDA ON: 2/23/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY RECEIVED AN ERROR CODE JUST BEFORE THE PROCEDURE WAS TO BEGIN. THE PT WAS UNDER GENERAL ANESTHESIA WHEN THE ERROR CODE OCCURRED. DURING BOOT-UP THE UNIT FUNCTIONED CORRECTLY, BUT ONCE THE ERROR CODE WAS RECEIVED THE FIRST TIME, EACH RE-BOOT OF THE CONSOLE DISPLAYED THE ERROR CODE. THE PT WAS AWAKENED FROM GENERAL ANESTHESIA AND WAS OKAY. THE CASE WAS CANCELLED AND THE PT WAS MOVED TO ANOTHER FACILITY TO PERFORM THE SURGERY. THERE WAS NO PT INJURY.

    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 83 YR