BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2211640 · Received August 5, 2011

    Report

    Report Number
    2028159-2011-00902
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 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
    BR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WHEN HE TURNED ON THE SYSTEM, IT DISPLAYED A SYSTEM MESSAGE INDICATING - "AIR/FLUID MODULE: VIT, FRAG, VACUUM, SCISSORS AND VFI ARE NOT AVAILABLE". THE COMPANY REPRESENTATIVE REPLACED THE AIR/FLUID (A/F) CONTROLLER PRINTED CIRCUIT BOARD (PCB) AND THE PRESSURE VACUUM MANIFOLD. PREVENTIVE MAINTENANCE WAS ALSO PERFORMED. NO SAMPLES WERE RETURNED FOR EVALUATION. THE CUSTOMER REPORTED EVENT OF LOW ASPIRATION WAS NOT CONFIRMED. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING SURGERY, THE SURGEON NOTED THAT THE SYSTEM WAS NOT ASPIRATING AS EXPECTED. THE SYSTEM WAS EXCHANGED, AND THE SURGERY WAS COMPLETED AFTER A DELAY OF FIVE MINUTES. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK