BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS SENSORMAT PADS

    MDR report key: 7929349 · Received October 3, 2018

    Report

    Report Number
    7929349
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    August 9, 2018
    Report Date
    September 27, 2018
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BED CHECK DID NOT ALARM WHEN PATIENT GOT OUT OF BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772676 CORDLESS SENSORMAT PADS MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC. 74050 A0318

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA