BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMNICLEAN UV-C DISINFECTION ROBOT

    MDR report key: 23758313 · Received December 9, 2025

    Report

    Report Number
    MW5180182
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    June 1, 2025
    Report Date
    December 4, 2025
    Manufacturer
    OHMNILABS, INC.
    Product Code
    QXJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN THE EARLY SUMMER OF 2025, THE OHMNICLEAN UV-C DEVICE, MANUFACTURED BY OHMNILABS (OHMNILABS.COM), STARTED A FIRE AT THE (B)(6) MEDICAL CENTER. THE FIRE CAUSED SIGNIFICANT SMOKE DAMAGE ON THE 1ST FLOOR OF (B)(6) MEDICAL CENTER. THE OHMNICLEAN DEVICE WAS IMPROPERLY PROMOTED TO THE (B)(6) FOR USE AS A WHOLE ROOM MICROBIAL REDUCTION DEVICE (PRODUCT CODE QXJ) BUT HAS NOT BEEN CLEARED BY THE FDA FOR USE IN A HOSPITAL. THE EVENT WENT UN-REPORTED TO MAUDE. THE LOCATION OF THE FIRE WAS (B)(6) MEDICAL CENTER, MAIN PHONE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590626 OHMNICLEAN UV-C DISINFECTION ROBOT WHOLE ROOM MICROBIAL REDUCTION DEVICE QXJ OHMNILABS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening