BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1257543 · Received November 21, 2008

    Report

    Report Number
    2028159-2008-00423
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR.
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE U/S PCB WAS NOT WORKING. THE U/S PCB WAS REPLACED AND WILL BE SENT FOR IN HOUSE TESTING. THE SYSTEM WAS THEN TESTED, AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED, WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THERE WAS NO U/S OSCILLATION DURING THE TUNING TEST. THE SYSTEM DISPLAYED "TUNED". THE SURGEON COULD NOT START SURGERY AND THE CASE WAS CANCELLED. 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 CTR. STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI