BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1940824 · Received December 17, 2010

    Report

    Report Number
    2028159-2010-02365
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 17, 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
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED AND NO ADD'L INFO WAS PROVIDED. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED THE SYSTEM HAD A LOUD POPPING SOUND, THE SCREEN WAS GRAYED OUT AND THE TOUCH SCREEN FROZE. THE FACILITY CLAMPED OFF THE LINES AND NO SOFT EYE OCCURRED. A HARD REBOOT WAS DONE AND THE STAFF DISCOVERED THE SUPPLY PRESSURE WAS HIGH. THE PRESSURE WAS LOWERED AND THE CASE WAS COMPLETED AFTER A 10 MIN DELAY. NO PT INJURY OR HARM REPORTED. ADD'L F/U INFO HAS BEEN REQUESTED.

    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