BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2092849 · Received May 5, 2011

    Report

    Report Number
    2028159-2011-00493
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 5, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. PREVENTIVE MAINTENANCE WAS THEN PERFORMED AND THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLES ARE RETURNING FOR EVAL. ROOT CAUSE HAS NOT BEEN DETERMINED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A BIOMED REPORTED THAT DURING SURGERY, THE STAFF WAS UNABLE TO ADJUST THE INFUSION PRESSURE SETTING. THEY ATTEMPTED TO LOWER IT FROM THEIR NORMAL SETTING AND THE INFUSION STOPPED. THERE WAS NO HARM 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 UNK