BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 2092826 · Received May 5, 2011

    Report

    Report Number
    2028159-2011-00463
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND CALIBRATED THE TOUCH SCREEN. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. THERE WERE NO PARTS REPLACED. THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE TOUCHSCREEN STOPPED RESPONDING DURING A VITRECTOMY PROCEDURE. THE CONSOLE WAS REPLACED BY ANOTHER SYSTEM TO COMPLETE THE CASE FOLLOWING A 30 MIN DELAY. THERE WAS NO HARM OR INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1