BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW ALL

    MDR report key: 23843430 · Received December 18, 2025

    Report

    Report Number
    3009591865-2025-00039
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 21, 2025
    Report Date
    November 18, 2025
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    UDI-DI
    00670482000494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BED-EXIT ALARM ALLEGEDLY FAILED TO TRANSMIT A SIGNAL TO THE NURSE CALL PANEL. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172384 OOK SNOW ALL HOSPITAL BED FNL UMANO MEDICAL INC 200-0000 00670482000494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown