BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON 36

    MDR report key: 23736470 · Received December 8, 2025

    Report

    Report Number
    23736470
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    October 27, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ULTRA CLEAN SYSTEMS, INC.
    Product Code
    FLG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GETINGE ULTRACLEAN DOES NOT HAVE AN EOS [END OF SUPPORT] DATE BUT NOBODY CAN GET PARTS, INCLUDING INTERNAL GETINGE. A COMPANY WAS ACQUIRED, AND NO NEW PART NUMBERS ARE AVAILABLE TO PURCHASE. TRITON 36 AND TRITON 72 MODELS. MANUFACTURER RESPONSE FOR CLEANING SYSTEM, ULTRACLEAN (PER SITE REPORTER). GETINGE IS AWARE AND IS FACING THE SAME CHALLENGES ACQUIRING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156951 TRITON 36 CLEANER, ULTRASONIC, MEDICAL INSTRUMENT FLG ULTRA CLEAN SYSTEMS, INC. 36

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown