BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED-CHECK CLASSIC CHECK

    MDR report key: 2827137 · Received July 9, 2012

    Report

    Report Number
    1929691-2012-00002
    Event Type
    Injury
    Date Received
    July 9, 2012
    Date of Event
    May 3, 2012
    Report Date
    June 29, 2012
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR (SSS) RECEIVED 3 COMPLETED MEDWATCH FORMS VIA MAIL FOR THIS INCIDENT. FOLLOW UP WITH FACILITY INDICATED THAT CHAIR AND BED SENSORMAT PADS WERE INVOLVED IN THIS INCIDENT, BUT THAT BOTH HAD BEEN DISCARDED AND WOULD NOT BE RETURNED FOR EVAL. FACILITY¿S USE OF THE BED PAD IS UNCLEAR IN THIS INCIDENT. MULTIPLE CONTACTS WITH FACILITY WERE ATTEMPTED FROM (B)(4) 2012 IN AN ATTEMPT TO HAVE ANY DEVICES INVOLVED IN THIS INCIDENT RETURNED. FACILITY WAS ABLE TO RETURN THE BED-CHECK CLASSIC CHECK MONITOR INVOLVED IN THIS INCIDENT, AND IT WAS RECEIVED BY SSS ON 06/20/2012. VISUAL INSPECTION WAS CONDUCTED AND USER DAMAGE WAS NOTED TO THE VELCRO STRAP USED TO MOUNT THE MONITOR- THE STRAP HAD BEEN CUT. FULL FUNCTIONAL TESTING WAS CONDUCTED BY SSS AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS. ANY ALLEGED FAILURE COULD NOT BE DUPLICATED WITH THE MONITOR RETURNED. BED AND CHAIR SENSORMAT PADS WERE DISCARDED, SO COULD NOT BE EVALUATED FOR FUNCTIONALITY OR MFG DEFECTS. AT THIS TIME NO CONCLUSIONS CAN BE DRAWN AS TO THE CAUSE OF THE ALLEGED FAILURE IN THIS INSTANCE. NO USER DAMAGE WAS FOUND TO THE MONITOR THAT COULD EXPLAIN A NO ALARM CONDITION. MOST LIKELY THE USER FACILITY¿S REPORT THAT CHAIR SENSOR USE IN BED APPLICATION IS CORRECT AS A CAUSE OF THE NO ALARM CONDITION. THE CHAIR SENSOR WOULD HAVE A SMALLER ACTIVATION AREA. USER FACILITY WILL BE SENT CLOSE-OUT LETTER INCLUDING WARNINGS FOUND IN THE USER GUIDE TO TEST THE MONITORING SYSTEM BEFORE EACH USE, AND INSTRUCTIONS TO USE BED AND CHAIR SENSORMAT PADS IN APPLICATIONS IN ACCORDANCE WITH LABELING.

    Description of Event or Problem · 1

    PT PRESENTED TO THE ED ON (B)(6) 2012, AND ADMITTED WITH UTI/SEPSIS. THE PT HAS A HISTORY OF DEMENTIA AND ORTHOSTATIC HYPOTENSION. THE PT EXITED THE BED AFTER HER HUSBAND, WHO AT THE TIME HAD BEEN AT THE BEDSIDE, WENT INTO THE RESTROOM. THE BFM ALARM DID NOT ALARM. THE PT FELL AND IT WAS DISCOVERED THAT SHE HAD A FRACTURED RIGHT HIP. INVESTIGATION REVEALED THAT THE CHAIR SENSOR WHICH IS IDENTICAL TO THE BED SENSOR EXCEPT FOR THE LENGTH, WAS CONNECTED TO THE BED FALL MONITOR. THEREFORE THE REASON THE ALARM DID NOT SOUND. ON (B)(6) 2012, THE PT UNDERWENT A RIGHT BIPOLAR HEMIARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED-CHECK CLASSIC CHECK BED-CHECK KMI STANLEY SECURITY SOLUTIONS, INC. 72020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention