BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 7160948 · Received January 3, 2018

    Report

    Report Number
    2028159-2018-00029
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 6, 2017
    Report Date
    March 29, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2017-102216.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAY TURNED WHITE. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS ABLE TO REPLICATE THE REPORTED EVENT. THE COMPUTER MEMORY CARD WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM WAS MANUFACTURED ON JUNE 11, 2014. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CAN BE ATTRIBUTED TO A NONCONFORMING COMPUTER MEMORY CARD. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE SYSTEM SUDDENLY EXPERIENCED A WHITE SCREEN DUE TO EQUIPMENT FAILURE. THE STAFF TRIED REBOOTING THE SYSTEM BUT THE ISSUE WAS NOT RESOLVED. THE SURGERY WAS STOPPED WHILE THE SYSTEM WAS EXCHANGED. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6674 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP-CHINA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other