BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANLEY BED ALARM

    MDR report key: 11759739 · Received May 3, 2021

    Report

    Report Number
    11759739
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    March 28, 2021
    Report Date
    April 22, 2021
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT CARE TECH WALKED INTO ROOM AND FOUND PATIENT FACE DOWN ON FLOOR MAT NEXT TO BED. RN WAS CALLED INTO ROOM FOR ASSISTANCE. PATIENT STATED THEY WANTED TO SIT UP AND DIDN'T REALIZE HOW CLOSE TO THE EDGE OF THE BED THEY WERE. PATIENT'S BED ALARM WAS ACTIVE, BUT DID NOT SOUND WHEN PATIENT GOT OUT OF BED. NEW ALARM WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661653 STANLEY BED ALARM MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC. 74030

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA