BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 2240888 · Received August 16, 2011

    Report

    Report Number
    1518293-2011-00136
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6): THE CUSTOMER REPORTS THAT A STAFF TECHNOLOGIST WAS PREPARING THE INJECTOR SYSTEM FOR A PROCEDURE. TECHNOLOGIST HAD LOADED THE SYRINGES ONTO THE INJECTOR AND WAS MOVING THE POWERHEAD INTO POSITION WHEN THE CEILING SUSPENSION BROKE. THE SUSPENSION FELL, HITTING THE TECHNOLOGIST (APPROX (B)(6) FEMALE) ON THE RIGHT SHOULDER. TECHNOLOGIST WAS SENT TO EMPLOYEE HEALTH FOR TREATMENT. TECHNOLOGIST WAS GIVEN MEDICATION FOR SORENESS, BUT WAS RETURNED TO AND CONTINUES TO WORK. CUSTOMER DOES NOT REPORT THE TECHNOLOGIST IS SCHEDULED FOR A PHYSICIAN APPOINTMENT DUE TO CONTINUED SORENESS IN THE SHOULDER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK