BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1834412 · Received September 10, 2010

    Report

    Report Number
    2028159-2010-01722
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 11, 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM FROZE" (NO DISPLAY OR DISPLAY FAILURE). A NURSE REPORTED THE SYSTEM FROZE DURING THE CASE. THE SURGEON WAS ATTEMPTING TO SWITCH TO A DIFFERENT GAUGE AT THE TIME OF THE EVENT. THE SYSTEM WAS REBOOTED AND THE CASE WAS COMPLETED. THERE HAVE NOT BEEN ANY ADDITIONAL ISSUES WITH THE SYSTEM SINCE THIS EVENT. 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