BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED CHECK

    MDR report key: 6906774 · Received October 2, 2017

    Report

    Report Number
    6906774
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 3, 2017
    Report Date
    September 8, 2017
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.,
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PLACED ON CHAIR WITH CHAIR CHECK IN PLACE AND ACTIVATED. FIVE MINUTES LATER, PATIENT SLID FROM CHAIR TO FLOOR AND THE CHAIR CHECK DID NOT ALARM. THE PATIENT SUFFERED NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687498 BED CHECK MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC., 72100

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR