BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANLEY M200

    MDR report key: 7548636 · Received May 29, 2018

    Report

    Report Number
    7548636
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 15, 2018
    Report Date
    May 22, 2018
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ALARM MAT CONNECTION PORT AT THE BOTTOM OF THE BOX DID NOT ALLOW THE CONNECTION TO CLICK IN AND LOCK IN. IT DID ACCEPT THE CABLE, AND THE CABLE SOUND INDICATOR SOUNDED AS THOUGH THE CONNECTION WAS MADE BETWEEN THE MAT UNDER THE PATIENT AND THE ALARM BOX. WITH ANY SLIGHT MOVEMENT OF THE CABLE OR EVEN GRAVITY FOR ANY PERIOD OF TIME, THE CONNECTOR SLIPS OUT OF THE ALARM BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391663 STANLEY M200 MONITOR, BED PATIENT KMI STANLEY SECURITY SOLUTIONS, INC. M200

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention