BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULRICHEASYINJECT MAX

    MDR report key: 21384158 · Received February 14, 2025

    Report

    Report Number
    21384158
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ULRICH MEDICAL USA, INC.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INJECTOR MALFUNCTION ERROR 1538 WHILE ADMINISTERING CONTRAST. PT RECEIVED 25 ML RESULTING IN SUBOPTIMAL SCAN FOR PE. CT DEPT CONTACTED RADIOLOGIST WHO SUGGESTED REPEATING SCAN AND CONTRAST BOLUS. CT DEPT ALSO CONTACTED SERVICE DEPT FOR ULRICH INJECTOR. THEY INSTRUCTED TO REBOOT SCANNER AND PROCEED. NO FURTHER ACTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624178 ULRICHEASYINJECT MAX SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED IZQ ULRICH MEDICAL USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female