BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1940120 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02427
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 29, 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
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS PERFORMED, BUT THE INVESTIGATION HAS NOT BEEN COMPLETED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED. THE BIOMED WAS UNSURE OF PT IMPACT, AND PROVIDED THE COMPANY WITH CONTACT INFO FOR A NURSE, FROM WHOM TO OBTAIN ADD'L INFO. NUMEROUS ATTEMPTS HAVE BEEN MADE TO CONTACT THE NURSE, BUT NO RESPONSE HAS BEEN RECEIVED.

    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