BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 2072408 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00338
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE ERROR OCCURRED AND THE UNIT STOPPED WORKING DURING A PROCEDURE. THE UNIT WAS EXCHANGED TO COMPLETE THE CASE. ADDITIONAL INFO WAS RECEIVED FROM THE NURSE REPORTING THE SYSTEM MESSAGE OCCURRED DURING PRIMING AND THE SYSTEM WAS RE-PRIMED SUCCESSFULLY. ABOUT THIRTY MINUTES INTO THE CASE, A SYSTEM MESSAGE DISPLAYED WHILE THE SURGEON WAS USING THE CUTTER. THE NURSE SELECTED THE "QUICK START" OPTION TO RESUME THE PROCEDURE; HOWEVER, THE SYSTEM WOULD NOT PRIME AFTERWARDS. THE CASSETTE WAS SUBSEQUENTLY REPLACED AND PRIMING WAS SUCCESSFUL. ANOTHER SYSTEM MESSAGE DISPLAYED WHEN THE SURGEON INITIATED THE FOOTSWITCH. ANOTHER SYSTEM WAS USED TO COMPLETE THE CASE FOLLOWING A 15 MINUTE 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 CTR CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1