BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW

    MDR report key: 11633168 · Received April 8, 2021

    Report

    Report Number
    3009591865-2021-00005
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 7, 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

    USER CONTACTED THE TECHNICAL SERVICE OF THE MANUFACTURER ALLEGING THAT BED EXITING DETECTION WAS BEING SIGNALED LOCALLY BUT NOT AT THE NURSE STATION. NO PATIENT INVOLVEMENT OR INCIDENT ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534603 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC FL36

    Patients

    Seq Age Sex Outcome Treatment
    1