BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2092161 · Received April 27, 2011

    Report

    Report Number
    2028159-2011-00445
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM, REPLACED THE HOME SENSOR PRINTED CIRCUIT BOARD (PCB) AND THE FOOTSWITCH. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. FOOTSWITCH IS RETURNING FOR EVAL. ADDITIONAL INFO REGARDING PRODUCT EVAL IS PENDING. ROOT CAUSE: 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT WHEN SWITCHING TO AIR INFUSION, THEY GOT SALINE INSTEAD. A SYSTEM MESSAGE WAS DISPLAYED, WHICH THEY WERE ABLE TO CLEAR VIA THE QUICK START FUNCTION. AT THAT TIME THE REMOTE CONTROL WAS NOT FUNCTIONING. THE SURGEON PERFORMED MANUAL EXTRUSION AND THEY USED THE SYSTEM TO COMPLETE THE CASE. THERE WAS NO HARM TO THE PT.

    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 UNK