BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 2872028 · Received December 11, 2012

    Report

    Report Number
    1518293-2012-00227
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 11, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    PMA / PMN Number
    K031339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS NOT ABLE TO DUPLICATE THE COMPLAINT OF THE RAM MOVING IN THE OPPOSITE DIRECTION. FSE FOUND DRIED CONTRAST ON THE POWERHEAD KEYPAD. FSE REPLACED THE KEYPAD SINCE THE TOUCH SENSORS WERE DISCOLORED, AND CALIBRATED THE SYSTEM. FSE VERIFIED PROPER OPERATION PER ADV SERVICE MANUAL AND COMPLETED SERVICE CHECKLIST 820896. ALL VALUES WERE WITHIN SPECIFICATION AND THE UNIT WAS RETURNED TO CUSTOMER FOR SERVICE.

    Description of Event or Problem · 1

    (B)(4): CUSTOMER REPORTS VIA PHONE THAT THEY HAVE BEEN EXPERIENCING ISSUES WHEN LOADING 200ML SYRINGES WITH CONTRAST. THEY WILL BE RETRACTING THE RAM, AND IT STOPS ABOUT HALFWAY, THEN STARTS UP AGAIN. ONCE LOADED, THEY THEN REPORTED THE MANUAL KNOB IS VERY HARD TO TURN. THEN ON WEDNESDAY, STAFF WAS LOADING A SYRINGE, IN PREPARATION FOR A PROCEDURE, WHEN SHE PRESSED THE BUTTON TO RETRACT THE RAM, IT ACTUALLY MOVED FORWARD. INJECTOR WAS NOT CONNECTED TO A PT. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV DOMESTIC BASIC SYS DXT LIEBEL-FLARSHEIM CO. CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA