BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RO, MIILENIUM HX, 4118, 115~, 60HZ

    MDR report key: 22060110 · Received May 21, 2025

    Report

    Report Number
    22060110
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 6, 2025
    Manufacturer
    EVOQUA WATER TECHNOLOGIES LLC
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    [REDACTED], MHX RO #41 [REDACTED] WOULD NOT TURN ON. CLINICAL ENGINEERING DISCOVERED THE FUSE WAS MELTED INTO THE FUSE BOX. THIS WAS NOT THE FIRST MHX RO TO HAVE THIS HAPPENED. IN REVIEWING SERVICE REPORTS, I DISCOVERED THE FOLLOWING MHX ROS HAD THE FUSE BOX REPAIRED FOR SIMILAR REASON WITHIN THE PAST 7 MONTHS. [REDACTED] MHX RO #10 [REDACTED], [REDACTED] MHX RO #21 [REDACTED], [REDACTED] MHX RO #40 [REDACTED], [REDACTED] MHX RO #11 [REDACTED]. THERE ARE 9 OF THE PORTABLE ROS IN THE NETWORK. 5 OF THE 9 HAVE EXPERIENCED THIS ISSUE. THE MACHINES HAVE HAD PREVENTATIVE MAINTENANCE [PM] PERFORMED AS REQUIRED BY MANUFACTURER. THE MACHINES ARE COVERED BY SERVICE CONTRACTS FOR PM WITH EVOQUA NOT WITH CLINICAL ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886471 RO, MIILENIUM HX, 4118, 115~, 60HZ SUBSYSTEM, WATER PURIFICATION FIP EVOQUA WATER TECHNOLOGIES LLC W3T577749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown