BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINOS DRF MAX

    MDR report key: 23531374 · Received November 12, 2025

    Report

    Report Number
    3004977335-2025-00131
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 1, 2025
    Report Date
    April 14, 2026
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    04056869009155
    PMA / PMN Number
    K173639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE INVESTIGATION DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION, AND NO NON-CONFORMITY WAS IDENTIFIED. IT WAS STATED THAT DURING AN EXAMINATION OF AN INFANT THE COMPRESSION ARM SUDDENLY EXTENDED OUTWARDS AND HIT THE BACK OF THE CHAIR. THE CHILD ALMOST FELL FORWARDS BUT WAS CAUGHT BY THEIR PARENT. THE INVESTIGATION IDENTIFIED THAT THE CHAIR AND THE ¿CAR SEAT STYLE SEAT¿ FOR THE INFANT ARE NOT PART OF THE LUMINOS DRF MAX SYSTEM AND WERE NOT PROVIDED BY SIEMENS HEALTHINEERS. IT IS THE RESPONSIBILITY OF THE OPERATOR TO POSITION AND SECURE THE CHILD SAFELY DURING EXAMINATIONS. THE ANALYSIS OF THE LOG FILES CONFIRMED A COMPRESSION MOVEMENT AT THE PROVIDED TIME STAMP INITIATED AT THE REMOTE CONTROL CONSOLE (RCC) IN THE EXAMINATION ROOM. NO FAILURE COULD BE DETERMINED WITHIN THE LOG FILES. FOR A DEEPER ANALYSIS THE AFFECTED RCC WAS RETURNED. THE INVESTIGATION OF THE RCC, ESPECIALLY OF THE COMPRESSION JOYSTICK, DID NOT INDICATE ANY MALFUNCTION. NO AUTONOMOUS TRIGGER COULD BE IDENTIFIED. THE COMPRESSION JOYSTICK AT THE RCC IS NOT EQUIPPED WITH A DMG FUNCTIONALITY. THUS, THIS JOYSTICK COULD ALSO BE ACTUATED ACCIDENTALLY. A POSSIBLE ERROR ACCUMULATION OR EVEN A SYSTEMATIC ERROR, WHICH WOULD LEAD TO A CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE DETERMINED BY THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3, H6: INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE): NO GENERAL PROBLEM HAS BEEN DETECTED FOR THE INSTALLED BASE WHICH REQUIRES IMMEDIATE ACTION. MANUFACTURER'S PRELIMINARY RESULTS AND CONCLUSION: THE ROOT CAUSE OF THE EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS OBTAINED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE ASSOCIATED WITH THE LUMINOS DRF MAX SYSTEM. AN 11-WEEK-OLD PATIENT WAS UNDERGOING A SWALLOW TEST WHEN SUDDENLY THE COMPRESSION CONE ARM OF THE SYSTEM EXTENDED OUTWARDS. THE CHILD WAS SEATED IN A CAR SEAT-STYLE SEAT WHICH WAS STRAPPED TO THE MAIN SEAT FOR ADULT PATIENTS. THE COMPRESSION ARM HIT THE BACK OF THIS CHAIR WITH A LOUD SOUND, WHICH CAUSED THE CHILD TO ALMOST FALL FORWARDS ONTO THE FLOOR IF THEY WERE NOT CAUGHT BY THEIR PARENT WHO WAS STANDING RIGHT IN FRONT OF THEM. THE ISSUE IS CURRENTLY NOT UNDERSTOOD. IT IS CURRENTLY UNCLEAR WHETHER THERE WAS ANY SYSTEM MALFUNCTION. NO INJURY TO THE PATIENT, STAFF, OR OTHER PEOPLE OCCURRED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465734 LUMINOS DRF MAX INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10762471 04056869009155

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male