BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT POWER INJECTOR

    MDR report key: 730359 · Received June 15, 2006

    Report

    Report Number
    730359
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    April 17, 2006
    Report Date
    June 15, 2006
    Manufacturer
    MALLINCKRODT, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    AS THE TECHNICIAN WAS REMOVING THE SYRINGE FROM THE INJECTOR, THE POWER HEAD AND ARM FELL FROM THE CEILING SUSPENSION. A POWER INJECTOR IS A UNIT DESIGNED TO ADMINISTER A MEASURED DOSE OF CONTRAST TO A PATIENT AT A MEASURED RATE/SPEED. AN INJECTOR CAN BE EITHER FLOOR MOUNTED OR CEILING MOUNTED DEPENDING ON FACILITY PREFERENCE. DURING THE INJECTION, THE UNIT IS OVER THE PATIENT'S BED. AFTER THE INJECTION, THE DEVICE IS MOVED TO THE SIDE AND THE SYRINGE(S) ARE THEN REMOVED BY THE TECHNOLOGIST. UPON INSPECTION BY BIOMED, IT WAS DISCOVERED THAT A PIN THAT SHOULD HAVE BEEN INSTALLED ON THE UNIT HAD NEVER BEEN PUT IN PLACE. IT WAS JUST A MATTER OF TIME THAT THIS UNIT WOULD HAVE FALLEN. THE INCIDENT WAS REPORTED TO MALLINCKRODT'S PRODUCT MONITORING LINE AS WELL AS THE SERVICE DEPT. THE MISSING COLLAR SCREW (PIN) WAS INSTALLED BY MALLINCKRODT'S FIELD SERVICE ENGINEER.NOTE: PER THE TECHNOLOGIST, THEY RECEIVED A LETTER FROM MALLINCKRODT STATING THEY SUBMITTED A MEDICAL DEVICE REPORT CONCERNING THIS EVENT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT POWER INJECTOR POWER INJECTOR DXT MALLINCKRODT, INC. CT 9000 ADV *

    Patients

    Seq Age Sex Outcome Treatment
    1 *