BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2241410 · Received August 18, 2011

    Report

    Report Number
    2028159-2011-00963
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE ANY PROBLEMS. HOWEVER, THE COMPANY REPRESENTATIVE WAS ABLE TO ISOLATE AND DUPLICATE PROBLEMS WITH THE SITES NITROGEN BOTTLE REGULATOR. THE COMPANY REPRESENTATIVE STATED THAT THE REGULATOR WAS NOT REGISTERING ANY READINGS OTHER THAN THE REMAINING BOTTLE PRESSURE AND WAS NOT SHOWING ANY NITROGEN EXITING TO THE SYSTEM. THE COMPANY REPRESENTATIVE REPLACED THE REGULATOR TO RESOLVE THIS ISSUE. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CAN BE ATTRIBUTED TO THE CUSTOMER'S NONCONFORMING NITROGEN TANK REGULATOR. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SYSTEM MESSAGE WAS DISPLAYED DURING A PROCEDURE THAT WAS UNABLE TO BE CLEARED. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO IMPACT TO THE PATIENT. THE CUSTOMER REPORTED THAT THEY LATER FOUND OUT THAT THE SOURCE REGULATOR WAS THE CAUSE OF THE EVENT, NOT THE CONSOLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1