BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS 500 CL/CDL

    MDR report key: 23177045 · Received September 30, 2025

    Report

    Report Number
    3008241044-2025-00001
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    March 3, 2025
    Report Date
    October 1, 2025
    Manufacturer
    STEELCO S.P.A.
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN MODIFIED IN THIS FOLLOW-UP REPORT: D4, G3, AND G6. AN ATTACHMENT HAS BEEN ADDED.

    Additional Manufacturer Narrative · 0

    THE MACHINE WAS INSPECTED. ALL COMPONENTS WERE FOUND TO BE CORRECTLY FIRE RESISTANT, WHICH CAUSED THEM NOT TO CATCH FIRE BUT RATHER TO MELT WHEN OVERHEATED. THE ISSUE WAS CREATED BY ACCIDENTAL MALFUNCTION OF THE HEATING ELEMENT THAT BLEW AND BY GRAVITY CAME IN CONTACT WITH ISOLATED WIRES AND MOTHERBOARD. THE WATER HEATING ELEMENT AND MAIN CONTROL BOARD WERE REPLACED. SEVERAL TEST CYCLES WERE SUCCESSFULLY RUN TO VERIFY THAT THE DEVICE WAS WORKING PROPERLY. THE WASHER-DISINFECTOR WAS RETURNED TO USE AFTER TWO WEEKS AND NO NEW ISSUES HAVE BEEN OBSERVED.

    Description of Event or Problem · 0

    THE HEATING ELEMENT OF THE WASHER-DISINFECTOR LOCATED IN THE SPD BLEW AND CAME IN CONTACT WITH ISOLATED WIRES. DUE TO THE CONTACT WITH A VERY HOT LEAD, THE SMALL WIRES MELTED, PRODUCING A STRONG, PERVASIVE SMELL IN THE HEALTHCARE FACILITY AND A SMALL AMOUNT OF SMOKE NEAR THE MACHINE. NO STAFF MEMBERS WERE HARMED NOR WERE PATIENTS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409634 DS 500 CL/CDL WASHER-DISINFECTOR MEC STEELCO S.P.A. DS 500 CL/CDL 2202012I3406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown