BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER.

    MDR report key: 1891070 · Received October 29, 2010

    Report

    Report Number
    2028159-2010-02103
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 29, 2010
    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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEMS. THE PNEUMATIC RFID PCB AND THE RFID CABLE WERE REPLACED AS A PREVENTATIVE MEASURE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE PNEUMATIC RFID PCB WILL BE SENT IN FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE DIATHERMY AND FRAGMENTATION FUNCTIONS WERE UNAVAILABLE DURING A CASE. SYSTEM MESSAGES WERE RECEIVED BUT THE NURSE COULD NOT RECALL WHICH ONES. THE SYSTEM WAS REBOOTED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT IMPACT REPORTED.

    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