BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED ALARM

    MDR report key: 11036258 · Received December 18, 2020

    Report

    Report Number
    11036258
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    December 7, 2020
    Report Date
    December 15, 2020
    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 HAD A BED ALARM IN PLACE. PATIENT WAS FOUND ON THE FLOOR WITH INJURIES, AND BED ALARM DID NOT GO OFF. AN OPEN WIRE WAS FOUND ON THE DEVICE AFTER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504685 BED ALARM MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA Other