BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 19990515 · Received August 15, 2024

    Report

    Report Number
    19990515
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    May 5, 2023
    Report Date
    November 14, 2023
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WENT TO ROTOR FOR EXPOSURE FOR A CHEST X-RAY ON A PATIENT. THE PATIENT COUGHED SO I KEPT ROTORING THINKING THE PATIENT WOULD BE ABLE TO RECOVER IN TIME FOR A NICE BIG BREATH EXPOSURE. BUT THAT IS WHEN I HEARD A POP FOR THE X-RAY TUBE. I ATTEMPTED TO TAKE AN EXPOSURE BUT NO IMAGE WAS ACQUIRED SO I SWAPPED OUT THE PORTABLES TO COMPLETE THE EXAM. WHEN I CAME BACK AFTER FINISHING THE EXAM THAT'S WHEN I NOTICED THE BURNING ELECTRICAL SMELL AS WELL AS [NAME REDACTED], WHO THEN PROMPTED TO ASSIST/ GUIDE ME THROUGH HANDLING THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164366 DRX-REVOLUTION MOBILE X-RAY SYSTEM SYSTEM, X-RAY, MOBILE IZL CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 122 YR Unknown