BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1842621 · Received September 1, 2010

    Report

    Report Number
    2028159-2010-01645
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 2, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS INDICATED NO ADDITIONAL, RELATED REPORTS FOR THIS SYSTEM. A REVIEW OF SERVICE REQUESTS FOR THE LAST 24 MONTHS INDICATED ONE ADDITIONAL, RELATED REPORT FOR THIS SYSTEM. NO SAMPLES WERE RETURNED. THE COMPANY SERVICE REPRESENTATIVE WAS UNABLE TO REPLICATE OR CONFIRM THE REPORTED EVENT IN THE FIELD AND FOUND THE SYSTEM TO MEET SPECIFICATION. THEREFORE, EVALUATION STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE CUSTOMER REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE, UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A BIOMEDICAL ENGINEER REPORTED MULTIPLE SYSTEM MESSAGES DURING A CASE. EACH TIME A SYSTEM MESSAGE WAS DISPLAYED, THE MACHINE WAS REBOOTED. THE CASE WAS COMPLETED WITH NO INJURY TO THE PATIENT.

    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