BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED-CHECK ST SENSORMAT PAD

    MDR report key: 3106297 · Received April 2, 2013

    Report

    Report Number
    1929691-2013-00002
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 19, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN INCIDENT WAS RETURNED FOR MFR'S EVAL. ON EVAL, A CONSTANT OPEN CIRCUIT CONDITION WAS NOTED. THE PAD WAS OPENED TO CHECK FOR MFG DEFECTS, WITH NONE FOUND. INTERNAL CONDITION OF THE MAT SHOWED SIGNS OF USE EITHER BEYOND THE WARRANTY PERIOD (14 DAYS) AND/OR WITH MULTIPLE PTS (LABELED SINGLE USE ONLY). FACILITY REPORTS THAT PROCEDURE IS TO CHECK FOR PROPER OPERATION EVERY SHIFT CHANGE, BUT NO RECORD OF WHETHER THIS WAS DONE IN THIS CASE. MOST LIKELY EXPLANTATION IS THAT UNIT HAD EXCEEDED ITS EXPECTED LIFE AND FAILED SHORTLY BEFORE THE INCIDENT.

    Description of Event or Problem · 1

    PER FORM 3500A REC'D FROM USER FACILITY: "WHEN THE PT STOOD UP FROM THE CHAIR, THE CHAIR SENSOR MAT DID NOT WORK. THE ALARM BOX INDICATED IT WAS ON BY THE GREEN LIGHT DISPLAY AND READY. SENSOR MAT AND ALARM BOX WERE REMOVED FROM SERVICE AND SENT TO BIOMEDICAL ENGINEERING FOR EVAL. IT WAS DETERMINED THAT THE CHAIR SENSOR PAD MALFUNCTIONED." F/U WITH FACILITY INDICATED THAT NO PT INJURY OCCURRED, AND THAT THE FAILURE TO ALARM WAS NOTED WHEN THE PT WAS BEING HELPED OUT OF HIS CHAIR BY STAFF. FACILITY CONTACT STATED THAT PROCEDURE IS TO CHECK MONITOR FOR PROPER OPERATION AT THE BEGINNING OF EVERY SHIFT, BUT CONTACT WAS UNABLE TO REPORT WHETHER THIS WAS CONFIRMED TO HAVE BEEN DOWN IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133860 BED-CHECK ST SENSORMAT PAD SENSORMAT KMI STANLEY SECURITY SOLUTIONS, INC. 73030 I0911

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR NONE REPORTED