BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 11768814 · Received May 4, 2021

    Report

    Report Number
    11768814
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 28, 2021
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    UDI-DI
    60889971019394
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROBLEMS WITH THE DRX-REVOLUTION MOBILE X-RAY SYSTEM STARTED WITH PATIENT IMAGES NOT SAVING IN CORRECT PATIENT EXAM AFTER EXPOSURE. X-RAY TECH WAS ABLE TO FIND CORRECT PATIENT IMAGE IN INCORRECT PATIENTS FOLDER. CARESTREAM HEALTH WAS NOTIFIED BY BIOMEDICAL TEAM AND WAS ONSITE TO DIAGNOSE THE ISSUE. LOG FILES WERE DOWNLOADED AND SENT TO CARESTREAM NATIONAL SUPPORT TEAM TO DETERMINE POSSIBLE CAUSE OF ISSUE. SETTING CHANGES, RECOMMENDED BY NATIONAL SUPPORT, WERE MADE ON THE DEVICES. ERRORS CONTINUED. CARESTREAM WAS PRESENT DAILY WITH ON-GOING TROUBLE SHOOTING. ERROR ESCALATED UP THROUGH EXECUTIVE TEAM. TWO WEEKS ON GOING WITH NO RESOLUTION. SAME ERROR ON PORTABLE AT SISTER HOSPITAL, ONLY COMMONALITY IS THAT BOTH PORTABLES ARE FIRST GENERATION REVOLUTION WITH SAME SOFTWARE VERSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668890 DRX-REVOLUTION MOBILE X-RAY SYSTEM SYSTEM, X-RAY, MOBILE IZL CARESTREAM HEALTH, INC. DRX-REVOLUTION MOBILE X-RAY SYSTEM 60889971019394

    Patients

    Seq Age Sex Outcome Treatment
    1