BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRIS MRI INJECTION SYSTEM

    MDR report key: 512240 · Received February 20, 2004

    Report

    Report Number
    512240
    Event Type
    Malfunction
    Date Received
    February 20, 2004
    Date of Event
    November 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    MEDRAD, INC.
    Product Code
    DQF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN IV LINE WAS CONNECTED TO THE PT AND THE INJECTOR WAS PRIMED TO START KVO [KEEP VEIN OPEN]. TO KEEP IV LINE OPEN, START WAS MASHED [PUSHED] ON THE INJECTOR. THE BUTTON MAY HAVE BEEN STUCK BECAUSE CONTRAST WAS INJECTED INSTEAD OF KVO. DOCTORS HAD TO RESCHEDULE STUDY UNTIL THE NEXT DAY. BEFORE USING THE INJECTOR AGAIN, BOTH SYRINGES WERE LOADED WITH WATER AND RAN THROUGH SET UP AND INJECTION AGAIN. SYSTEM OK'D. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRIS MRI INJECTION SYSTEM MRI INJECTOR DQF MEDRAD, INC. SDV200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR