BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA, EUROPEAN RACK

    MDR report key: 4071873 · Received August 12, 2014

    Report

    Report Number
    1518293-2014-00090
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REGIONAL SERVICE INVESTIGATED AND FOUND THE REPORT OF THE UNIT NOT BEING ABLE TO DETECT AIR WAS DUE TO A BAD POWERHEAD PCB BOARD. THE BOARD WAS REPLACED AND THE ISSUE WAS RESOLVED. SERVICE ALSO REPORTED CLEANING THE AIR DETECTION ADVANCED WARNING SYSTEM (ADAWS) OF EXCESS CONTRAST. UNIT WAS CHECKED FOR PROPER FUNCTION AND RETURNED TO THE CUSTOMER FOR SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE ILLUMENA INJECTOR SYSTEM AIR DETECTION ADVANCED WARNING SYSTEM (ADAWS) STOPPED WORKING. CUSTOMER RECOGNIZED THIS FAILURE, AND REMOVED THE INJECTOR FROM SERVICE, NO PATIENTS INVOLVED. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478985 ILLUMENA, EUROPEAN RACK DXT LIEBEL FLARSHEIM ILLUMENA, EUROPEAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK