BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK COCOON

    MDR report key: 24760506 · Received April 1, 2026

    Report

    Report Number
    3009591865-2026-00005
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 4, 2026
    Report Date
    May 21, 2026
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BED'S INTEGRETED BED-EXIT DETECTION SYSTEM ALLEGEDLY DID NOT TRANSMIT A SIGNAL TO THE NURSE CALL PANEL AS EXPECTED, AND THAT A PATIENT ALLEGEDLY FELL ON THE FLOOR. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470772 OOK COCOON HOSPITAL BED FNL UMANO MEDICAL INC. FL36

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown