BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS BED CHECK

    MDR report key: 6036609 · Received October 18, 2016

    Report

    Report Number
    6036609
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 12, 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

    PATIENT WAS REACHING FOR HIS BEDSIDE TABLE WHEN HIS LEGS SLID OFF THE SIDE OF THE BED AND THE REST OF HIS BODY FOLLOWED. BED CHECK DID NOT SOUND. WHEN THE DEVICE WAS CHECKED, IT WAS FOUND TO BE MALFUNCTIONING. PATIENT SUFFERED SMALL SKIN TEAR TO SCAPULAR REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689163 CORDLESS BED CHECK MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC 72100

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other OTHER, LOW RISE BED