BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1791482 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01411
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE POWER SUPPLY WAS REPLACED AS A PREVENTIVE MEASURE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE POWER SUPPLY HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT HARM/INJURY." (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "SCREEN WENT BLACK" (NO DISPLAY OR DISPLAY FAILURE). THE NURSE REPORTED THE SCREEN WENT BLACK. THE SYSTEM WAS REBOOTED 3 TIMES TO COMPLETE SURGERY. FOUR CASES WERE CANCELLED. ADDITIONAL INFORMATION RECEIVED STATED THE EVENT OCCURRED AT THE BEGINNING WHILE TUNING THE HANDPIECE. THE SYSTEM WAS TURNED OFF AND ON A FEW TIMES BEFORE IT STAYED ON TO PROCEED WITH THE CASE. THE CASE WAS COMPLETED AS PLANNED. NO PATIENT INJURY WAS 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 59 YR