BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBS REVOLUTION¿

    MDR report key: 24277861 · Received February 6, 2026

    Report

    Report Number
    24277861
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 20, 2026
    Report Date
    January 27, 2026
    Manufacturer
    DBMEDX INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BLADDER SCANNED BY NA [NURSE ASSISTANT] [REDACTED] AT APPROXIMATELY 1704 FOR 568CC. RN PERFORMED STRAIGHT CATHETERIZATION PER ORDER AT APPROXIMATELY 1830 FOR 1200CC WITHOUT COMPLICATION. NOTE: WE HAVE HAD CONTINUED ISSUES WITH THIS DEVICE. BD HAS COME IN AND TRAINED OUR STAFF ON THE PROPER WAY TO USE THE BLADDER SCANNER, BUT STAFF CONTINUE TO FIND THIS DEVICE DIFFICULT TO USE EVEN WHEN INSTRUCTIONS ARE FOLLOWED METICULOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342404 BBS REVOLUTION¿ TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX DBMEDX INC. PD-010-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown