BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 18191536 · Received November 22, 2023

    Report

    Report Number
    18191536
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 28, 2023
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE NURSING STAFF, THE PATIENT WAS OOB (OUT OF BED) AND THE BED ALARM FAILED TO ALARM TIMELY. WHEN THEY HEARD THE ALARM, THE PATIENT WAS ALREADY ON THE FLOOR. THUS, THE STAFF FEEL THAT THERE WAS A DELAY IN THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637176 DEROYAL MONITOR, BED PATIENT KMI DEROYAL INDUSTRIES, INC. M2100-SL2

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Female Required Intervention| H