BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2081359 · Received April 22, 2011

    Report

    Report Number
    2028159-2011-00409
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 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
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED AT THE END OF A PROCEDURE, THE FAN INSIDE THE MACHINE STARTED TO SPIN AND A LOUD NOISE WAS HEARD WHEN THE DOCTOR CHANGED FROM FLUID TO AIR WITH THE FOOTSWITCH. SUDDENLY, A RED STOP SIGN AND MESSAGE ERROR CODE DISPLAYED. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE SYSTEM WAS SHUT DOWN DURING THE PROCEDURE. THE SURGEON COMPLETED THE CASE BY MANUALLY INJECTING THE GAS. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    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