BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERADIUS

    MDR report key: 22649120 · Received July 29, 2025

    Report

    Report Number
    3003768277-2025-006991
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 15, 2025
    Report Date
    February 11, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K142708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE INVESTIGATION CONFIRMED THAT NO ISSUE WITH THE PEDAL BEING STUCK WAS REPORTED BY THE CUSTOMER AND THAT THE CUSTOMER INITIATED AN INQUIRY TO DETERMINE IF THEIR SYSTEM WAS AFFECTED BY FSCA 2024-IGT-PUN-003. PHILIPS RESPONDED TO THE CUSTOMER, CONFIRMING THAT THE SYSTEM IS NOT AFFECTED BY THE FSCA. AT THE TIME THIS CASE WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY ON RECURRENCE, AND AS SUCH THE INFORMATION WAS REPORTED. SINCE THAT TIME, IT WAS IDENTIFIED THAT NO MALFUNCTION OF THE PHILIPS SYSTEM OCCURRED. INVESTIGATION IDENTIFIED THAT THIS WAS A CUSTOMER INQUIRY REGARDING FSCA 2024-IGT-PUN-003. SINCE THERE WAS NO MALFUNCTION OF THE SYSTEM, PHILIPS CONCLUDED THAT THE COMPLAINT IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT SYSTEM'S WIRELESS FOOTSWITCH PEDALS WERE STUCK WHEN ACTIVATED. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827223 VERADIUS INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VERADIUS UNITY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown