BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RN+ FALLWATCH II

    MDR report key: 6033961 · Received October 17, 2016

    Report

    Report Number
    6033961
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    August 28, 2016
    Report Date
    September 20, 2016
    Manufacturer
    NURSE ASSIST, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS ASSISTING PATIENT TO GET OUT OF BED AND AMBULATE TO BEDSIDE COMMODE. THE BED ALARM SOUNDED AND WAS NOT IMMEDIATELY TURNED OFF DUE TO ASSISTING PATIENT. DURING THIS TIME FRAME OF LESS THAN 1 MINUTE, THE SOUND OF THE ALARM DECREASED AND THE SMELL OF SMOKE OCCURRED. THE DEVICE WAS IMMEDIATELY UNPLUGGED AND REMOVED FROM THE PATIENT ROOM. NO PATIENT OR STAFF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686169 RN+ FALLWATCH II MONITOR, BED PATIENT KMI NURSE ASSIST, INC. BPS-11RF

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NO| NO OTHER THERAPIES