BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM

    MDR report key: 21686970 · Received March 25, 2025

    Report

    Report Number
    21686970
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 18, 2025
    Report Date
    March 19, 2025
    Manufacturer
    EVOQUA WATER TECHNOLOGIES LLC
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE REVERSE OSMOSIS PORTION OF THE HEMODIALYSIS RUN IS MALFUNCTIONING ON THIS PRODUCT. WE HAVE SUBMITTED 89 WORK ORDERS ON 8 DIFFERENT MACHINES IN A SHORT AMOUNT OF TIME. THESE ARE NEW MACHINES. SERIAL NUMBERS: [REDACTED]. MANUFACTURER RESPONSE FOR HEMODIALYSIS MACHINE, EON (PER SITE REPORTER). SEND TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093477 EON PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM SUBSYSTEM, WATER PURIFICATION FIP EVOQUA WATER TECHNOLOGIES LLC W3T578348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male