BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1880195 · Received October 15, 2010

    Report

    Report Number
    2028159-2010-01996
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    September 15, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEMS. THE REP INSTALLED AND REMOVED A CASSETTE SEVERAL TIMES WITH OUT ANY PROBLEMS OR WARNINGS. THE MOTHER BOARD BATTERY WAS REPLACED AS A PRECAUTION. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE UNIT DISPLAYED A MESSAGE INDICATING CASSETTE BLOCKAGE BUT THEY WERE NOT ABLE TO VERIFY IT. THE CASSETTE WAS REMOVED AND REINSTALLED TWICE BEFORE MESSAGE CLEARED. THE PROCEDURE CONTINUED AND THE CASE WAS COMPLETED. A SECOND SYSTEM MESSAGE WAS REPORTED TO HAVE OCCURRED INDICATING THE MOTHERBOARD BATTERY WAS LOW. THERE WAS NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1