BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 600DS

    MDR report key: 3043000 · Received March 7, 2013

    Report

    Report Number
    2028159-2013-00389
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 5, 2013
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE LOW PRESSURE AIR SOURCE ASSEMBLY AND THE LPAS/ILLUMINATOR CONTROLLER ASSEMBLY WERE REPLACED. THE COMPANY REPRESENTATIVE ALSO REPLACED THE 3V ACCURUS BATTERY TO ADDRESS THE CPU BATTERY NONCONFORMITY. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE FLUID/GAS EXCHANGE DID NOT FUNCTION AND AN "ERROR OCCURRED IN THE CPU" DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SYSTEM WITH NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98509 ACCURUS 600DS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1