BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED-CHECK

    MDR report key: 6413106 · Received March 17, 2017

    Report

    Report Number
    1929691-2017-00009
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    October 13, 2016
    Report Date
    December 30, 2016
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT QUARANTINED BY USER FACILITY FOR RETURN AND EVALUATION. DEVICE NOT KEPT FOR RETURN BY FACILITY.

    Description of Event or Problem · 1

    PATIENT WAS FOUND LYING ON THE FLOOR. BED ALARM WAS PLUGGED INTO THE WALL AND UNIT WAS NOT ALARMING, UPON INSPECTION THE ALARM WAS NO LONGER SOUNDING APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195559 BED-CHECK BED PATIENT MONITOR KMI STANLEY SECURITY SOLUTIONS, INC. 74030 N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other