BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 1051245 · Received May 22, 2008

    Report

    Report Number
    1518293-2008-00187
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT. FIELD SERVICE ENGINEER FOUND J-BOW ARM BROKEN FROM SUSPENSION ARM AND HANGING BY POWERHEAD CABLE. FSE INSTALLED POWERHEAD INJECTOR ON REMOTE STAND, VERIFIED OPERATION PER INJECTOR SERVICE MANUAL. THIS IS A KNOWN ISSUE BEING ADDRESSED IN CAPA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO LF SERVICE DISPATCH THAT THE INJECTOR CEILING SUSPENSION HAD FAILED. INJECTOR HANGING BY THE INJECTOR CABLES. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV DOMESTIC BASIC SYS CT POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK