BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOK SNOW

    MDR report key: 11867139 · Received May 21, 2021

    Report

    Report Number
    3009591865-2021-00015
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 21, 2021
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER CONTACTED MANUFACTURER TO REPORT A PATIENT FALL. THE BED EXIT DETECTION SYSTEM HAD NOT BEEN SET UP AND PATIENT EXITING BED COULD NOT BE TRIGGED AND SIGNALED. THERE WAS NO INJURY ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763030 OOK SNOW MEDICAL BED FNL UMANO MEDICAL INC FL36

    Patients

    Seq Age Sex Outcome Treatment
    1