BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1891098 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02040
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED SYSTEM MESSAGE IN THE EVENT LOG. THE TRANSDUCER WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. A REVIEW OF COMPLAINTS AND SERVICE REQUESTS FOR THE LAST 24 MONTHS INDICATED NO ADD'L, RELATED REPORTS FOR THIS SYSTEM. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SYSTEM MESSAGE CODE APPEARED DURING A CASE AND COULD NOT BE REBOOTED SUCCESSFULLY. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1