BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT9000 ADV 115V/220V W/PED. +OB

    MDR report key: 2202673 · Received August 8, 2011

    Report

    Report Number
    1518293-2011-00142
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 13, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REGIONAL SERVICE ENGINEER INVESTIGATED AND FOUND NO PROBLEM WITH THE INJECTOR. THE INJECTOR WAS RETURNED TO FULL SERVICE. NO SIMILAR ISSUE REPORTED PRIOR TO THIS ON THIS UNIT. IN A DISCUSSION WITH COVIDIEN (B)(4), HE SAID THAT THIS IS NOT A COMMON ISSUE WITH THE ADV INJECTOR. A REVIEW OF CTS SHOWS 5 UNCOMMANDED MOVEMENT COMPLAINTS ON THE CT9000ADV INJECTOR SYSTEMS SINCE 2001. ALL WERE INVESTIGATED AND NONE COULD BE DUPLICATED AND NO PROBLEM FOUND BY SERVICE ENGINEER.

    Description of Event or Problem · 1

    COVIDIEN (B)(4) REGION REPORTS; CUSTOMER REPORTS; IN PREPARATION FOR A PATIENT PROCEDURE THEY PLACED AN EMPTY SYRINGE INTO THE INJECTOR AND LOADED CONTRAST MEDIA. THE STAFF THEN PURGED THE AIR FROM THE SYRINGE AND LOW PRESSURE TUBING. STAFF REPORTS THEY WALKED INTO THE CT CONTROL ROOM TO SELECT AN INJECTION PROTOCOL FROM THE CONTROL ROOM CONSOLE, WHEN THEY NOTED THE INJECTOR HAD ALREADY INJECTED THE CONTRAST MEDIA. INJECTOR SYRINGE AND TUBING WAS NOT ATTACHED TO PATIENT. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV 115V/220V W/PED. +OB CT POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA