BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2081158 · Received April 14, 2011

    Report

    Report Number
    2028159-2011-00370
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 16, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE PRESSURE VACUUM MANIFOLD. PREVENTATIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED DURING A VITRECTOMY PROCEDURE. THE SCREEN WAS LOCKED. THE SYSTEM HAD TO BE REBOOTED BUT THE PROBLEM PERSISTED. AS THE PROCEDURE WAS ALMOST OVER, IT WAS POSSIBLE FOR THE SURGEON TO COMPLETE IT MANUALLY WITH SUCCESS, WITH A 15 MINUTE DELAY. THERE WAS NO HARM TO THE PATIENT.

    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