BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED-CHECK

    MDR report key: 6300994 · Received February 3, 2017

    Report

    Report Number
    1929691-2017-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    September 27, 2016
    Report Date
    February 3, 2017
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE LOT CODE INFORMATION COULD BE PROVIDED BY THE FACILITY, AND DEVICE WAS NOT RETURNED. THEREFORE EVALUATION IS INCOMPLETE. USER INSTRUCTIONS PRINTED ON THE PAD STATE: "ALWAYS TEST THE SYSTEM BEFORE EACH USE", "DO NOT BEND, FOLD, SUBMERGE IN LIQUID, OR TAMPER WITH THE SENSORMAT PAD. IF THE SENSORMAT PAD IS FOLDED, IT MAY NOT FUNCTION PROPERLY.", AND "IF PRODUCT FAILS TO FUNCTION PROPERLY AT ANY TIME, STOP USE IMMEDIATELY AND REPLACE WITH NEW SENSORMAT PAD." USER FACILITY DISPOSED OF THE PRODUCT.

    Description of Event or Problem · 1

    PATIENT WAS SITTING IN THE CHAIR WITH CHAIR ALARM PAD ON AND PLUGGED IN TO RECEPTACLE WITH "BED ALARM." THE PATIENT STOOD UP AND FELL, THE ALARM DID NOT ALERT. NO PATIENT INJURY. A NURSE SAT ON THE CHAIR PAD SEVERAL TIMES BEFORE IT ALARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83570 BED-CHECK MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC. 73030 N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| O