BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1992824 · Received February 4, 2011

    Report

    Report Number
    2028159-2011-00093
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. ALL CONNECTIONS AND CABLES WERE INSPECTED. THE POWER CONTROLLER BOARD (PCB) WAS REPLACED FOR DIAGNOSTIC PURPOSES. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE PCB 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE UNIT INTERMITTENTLY GOES INTO POWER RECOVERY MODE AND RESTARTS ON ITS OWN. THIS EVENT WAS REPORTED TO HAVE HAPPENED THREE TIMES. EACH TIME, THE UNIT RESTARTED AND THE CASES WERE COMPLETED WITH NO PT IMPACT. THERE WAS A SLIGHT DELAY OF APPROX FIVE MINS WHILE THE SYSTEM REBOOTED.

    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