BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED CHECK

    MDR report key: 6249258 · Received January 13, 2017

    Report

    Report Number
    6249258
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Date of Event
    October 24, 2016
    Report Date
    November 25, 2016
    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

    BED CHECK NOT WORKING. BATTERIES WERE REPLACED, BED CHECK AND BOX RE-MARRIED WITHOUT RESOLUTION. REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32408 BED CHECK MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC., 72110

    Patients

    Seq Age Sex Outcome Treatment
    1 101 YR