BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW

    MDR report key: 11828756 · Received May 14, 2021

    Report

    Report Number
    3009591865-2021-00009
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 14, 2021
    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 · 1

    THE MANUFACTURER WAS CONTACTED BY CUSTOMER ALLEGING THAT THE SIGNAL FOR BED EXITING DETECTION WAS NOT BEING RECEIVED THROUGH THE NURSE CALL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720752 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC. FL36

    Patients

    Seq Age Sex Outcome Treatment
    1