BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1834401 · Received September 10, 2010

    Report

    Report Number
    2028159-2010-01743
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 13, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "SYSTEM SLOW" (DEVICE OPERATES DIFFERENTLY THAN EXPECTED); "ODOR" (DEVICE EMITS ODOR). A CUSTOMER REPORTED THE EQUIPMENT WAS SLOW AND THE VOICE IS IN ANOTHER IDIOM AND IT WAS NOT POSSIBLE TO RETURN TO (B)(6). THE CUSTOMER ALSO REPORTED A DIFFERENT ODOR. THE PROCEDURE WAS COMPLETED, BUT WITH DIFFICULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1