BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2210399 · Received August 8, 2011

    Report

    Report Number
    1518293-2011-00141
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 11, 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 REPLACED THE POWERHEAD PCB, CONSOLE CPU PCB AND MAIN CPU PCB. THE SERVICE ENGINEER TESTED THE UNIT AND FOUND THE INJECTOR WORKED WELL. A REVIEW OF CTS SHOWS ONE OTHER SIMILAR ISSUE REPORTED ON THIS UNIT. IN A DISCUSSION WITH COVIDIEN SERVICE MANAGER IN (B)(6), HE SAID THAT THIS IS NOT A COMMON ISSUE WITH THE (B)(4) INJECTOR. A REVIEW OF CTS SHOWS 5 UNCOMMANDED MOVEMENT COMPLAINTS ON THE (B)(4) INJECTOR SYSTEMS SINCE 2001. ALL WERE INVESTIGATED AND NONE COULD BE DUPLICATED AND NO PROBLEMS FOUND BY SERVICE ENGINEER.

    Description of Event or Problem · 1

    COVIDIEN APAC REGION REPORTS; CUSTOMER REPORTS; IN PREPARATION FOR A PT PROCEDURE THEY PLACED AND 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 FROM CONSOLE, WHEN THEY NOTED THE INJECTOR HAD ALREADY INJECTED THE CONTRAST MEDIA. INJECTOR SYRINGE AND TUBING WAS NOT ATTACHED TO PT. 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