BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 2097789 · Received May 6, 2011

    Report

    Report Number
    2097789
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ALCON
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ALCON CONSTELLATION LXT MACHINE STOPPED WORKING DURING THE CASE WITH A SYSTEM FAULT. THE SURGEON SAID THEY HAD JUST PULLED THE INSTRUMENTS OUT OF THE EYE WHEN THIS HAPPENED. THE INFUSION LINE WAS IMMEDIATELY CLAMPED. THE SURGEON REQUESTED TO HAVE THE OLD ALCON MACHINE BROUGHT INTO THE ROOM AND TO REMOVE THE CONSTELLATION MACHINE. THIS WAS DONE AND THE CASE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT. THIS COULD HAVE BEEN VERY DANGEROUS IF THE MACHINE HAD SUDDENLY STOPPED WORKING WHILE THE INSTRUMENTS WERE IN THE EYE. MACHINE SENT TO BIOMED. ALCON REPAIRED THE MACHINE: REPORTED A "RED STOP SIGN: FAULT 1012" AND TO REPAIR IT "REPLACED SUPERVISOR PCB WITH PART NUMBER 212-2948-502S". THE MACHINE WAS PLACED BACK IN SERVICE AFTER CHECK OUT TO MEET ALCON SPECIFICATIONS.====================== MANUFACTURER RESPONSE FOR VITRECTOMY MACHINE, CONSTELLATION (PER SITE REPORTER)======================SENT SERVICE TECHNICIAN TO REPAIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION VITRECTOMY MACHINE HQC ALCON 8065751550 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *