BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW

    MDR report key: 23404114 · Received October 28, 2025

    Report

    Report Number
    3009591865-2025-00026
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 8, 2025
    Report Date
    October 28, 2025
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ZONE 2 OF THE INTEGRATED BED EXIT DETECTION SYSTEM ON THE BED MAY NOT BE SUFFICIENTLY SENSITIVE, ALLEGING THAT THE PATIENT WAS FOUND SITTING ON THE EDGE OF THE BED WITHOUT TRIGGERING THE ALARM. THERE WAS NO INJURY RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125360 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC FL36

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown