BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON INC.

    MDR report key: 25166893 · Received May 14, 2026

    Report

    Report Number
    2020563-2026-00005
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    CANON INC.
    Product Code
    OWB
    UDI-DI
    04987670100222
    PMA / PMN Number
    K253584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT STATED THAT THE MATTRESS USED ON THE PATIENT TABLE IS TOO SHORT ON EACH SIDE WHICH MAY HAVE CONTRIBUTED TO THE INCIDENT. FURTHERMORE, THE MATTRESS USED AT THIS FACILITY WAS NOT MANUFACTURED BY OUR COMPANY.

    Description of Event or Problem · 0

    ON (B)(6) 2026 DURING THE TRANSFER FROM THE HOSPITAL BED / GURNEY TO THE PROCEDURE TABLE A PATIENT BECAME UNSTABLE WHILE BEING MOVED TO THE PROCEDURE TABLE AND SLIPPED. HOSPITAL STAFF CAUGHT THE PATIENT BEFORE HE HIT THE FLOOR AND THE PATIENT RECEIVED NO INJUIRES AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4383 CANON INC. INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB CANON INC. INFX-8000V/B6 04987670100222

    Patients

    Seq Age Sex Outcome Treatment
    1