BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, X-RAY, MOBILE

    MDR report key: 23341846 · Received October 20, 2025

    Report

    Report Number
    MW5177658
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    October 14, 2025
    Report Date
    October 14, 2025
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PEDIATRIC TRAUMA PATIENT BROUGHT INTO THE HOSPITAL DUE TO BEING STABBED. TRAUMA SURGEON REQUESTED CHEST XRAY, BUT IMAGING PLATE WOULD NOT CONNECT TO X-RAY MACHINE. CONSISTENT ISSUE WITH THESE SHIMADZU MACHINES NOT BEING ABLE TO CONNECT. WAITING 10 MINS TO CONNECT IS NOT AN ACCEPTABLE SITUATION FOR EMERGENCY SITUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451601 SYSTEM, X-RAY, MOBILE SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION MUX-200D-XC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention