BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2043243 · Received February 25, 2011

    Report

    Report Number
    2028159-2011-00182
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE FLUID/AIR INFUSION BUTTONS WERE NOT WORKING DURING A PROCEDURE. CONSEQUENTLY, THE SETTINGS WERE UNABLE TO BE ADJUSTED. THE FOOTSWITCH WAS EXCHANGED, BUT DID NOT SOLVE THE PROBLEM. AFTER THE CASE, WHEN DISCONNECTING ALL LINES, THE UNIT RETURNED TO NORMAL STATUS ALLOWING SETTINGS TO BE CHANGED BY THE USER. ADDITIONAL INFO WAS REQUESTED. ADDITIONAL INFO WAS RECEIVED INDICATING THE REPORTED EVENT OCCURRED THREE QUARTERS OF THE WAY INTO SURGERY. THE CASE WAS COMPLETED WITH NO HARM OR INJURIES TO THE PT.

    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