BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED CHECK ST CHAIR SENSORMAT

    MDR report key: 3005999 · Received March 6, 2013

    Report

    Report Number
    3005999
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.,
    Product Code
    KMN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE PATIENT STOOD UP FROM THE CHAIR, THE CHAIR SENSOR MAT DID NOT WORK. THE ALARM BOX INDICATED IT WAS ON BY THE GREEN LIGHT DISPLAY AND READY. SENSOR MAT AND ALARM BOX WERE REMOVED FROM SERVICE AND SENT TO BIOMEDICAL ENGINEERING FOR EVALUATION. IT WAS DETERMINED THAT THE CHAIR SENSOR PAD MALFUNCTIONED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CHAIR SENSOR WAS TO ALERT (AUDIBLE ALARM) STAFF WHEN PATIENT STOOD UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95182 BED CHECK ST CHAIR SENSORMAT MONITOR, CHAIR PATIENT KMN STANLEY SECURITY SOLUTIONS, INC., 73030 DC I0911

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR