BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOK SNOW

    MDR report key: 12887900 · Received November 29, 2021

    Report

    Report Number
    3009591865-2021-00024
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 29, 2021
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USER CALLED TECHNICAL SERVICE OF THE MANUFACTURER ALLEGING AN INTEGRATED BED EXIT DETECTION SYSTEM WOULD NOT SIGNAL PATIENT EXITING THE BED DURING THE NIGHT. HE MENTIONED ALSO THAT THE PATIENT WAS FOUND ON THE FLOOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779282 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC. FL36

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other