BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED-CHECK

    MDR report key: 6357337 · Received February 24, 2017

    Report

    Report Number
    1929691-2017-00003
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    October 24, 2016
    Report Date
    February 24, 2017
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS NOT KEPT FOR RETURN TO THE MANUFACTURER, NO FIRM CONCLUSIONS CAN BE DRAWN. IN SITU OBSERVATION WAS CONDUCTED AND AUDITS OF USAGE IN THE FACILITY WERE CONDUCTED. BASED ON THE DESCRIPTION OF THIS FAILURE (I.E. PRE-USAGE TEST WAS NOT SUCCESSFUL EVEN AFTER REPLACING BATTERIES), EITHER DAMAGE TO PAD OR TRANSMITTER CABLES HAD OCCURRED, OR AN INCORRECT TRANSMITTER WAS ASSOCIATED WITH THE DEVICE - BOTH POSSIBILITIES WERE SEEN DURING FACILITY USAGE AUDITS. SYSTEM USER GUIDE CONTAINS THE FOLLOWING STATEMENTS THAT, IF OBSERVED, MAY HAVE PREVENTED THIS OCCURRENCE: "USE CARE WHEN CONNECTING THE BED-CHECK TRANSMITTER AND SENSORMAT PADS. GENTLY REMOVE OR CONNECT CORDS. PULLING ON CORDS MAY DAMAGE THEM AND/OR RESULT IN SYSTEM FAILURE." & "TEST THE BED-CHECK MONITOR AND SENSORMAT PAD BEFORE EACH USE AND INSPECT THE CORDS AND PADS FOR SIGNS OF DAMAGE. REPLACE ANY COMPONENTS WITH SIGNS OF WEAR OR DAMAGE IMMEDIATELY." FACILITY DID NOT QUARANTINE, NO RETURN.

    Description of Event or Problem · 1

    FROM USER FACILITY REPORT: "BED CHECK NOT WORKING. BATTERIES WERE REPLACED, BED CHECK AND BOX RE-MARRIED WITHOUT RESOLUTION. REMOVED FROM SERVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139618 BED-CHECK MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC. 72110 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 101 YR Other