BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED-CHECK ST BED SENSORMAT PAD

    MDR report key: 2739947 · Received September 11, 2012

    Report

    Report Number
    1929691-2012-00007
    Event Type
    Injury
    Date Received
    September 11, 2012
    Date of Event
    July 5, 2012
    Report Date
    August 31, 2012
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY MANUFACTURER. TWO ITEMS OF USER DAMAGE WERE FOUND ON VISUAL INSPECTION: THE SENSORMAT PAD PLUG WAS DAMAGED AND DIFFICULT TO INSERT IN A MONITOR. FACILITY REPORTED THAT PLUG WAS STEPPED ON AFTER INCIDENT; SOME SLIGHT DAMAGE WAS FOUND FROM THE SENSORMAT PAD BEING FOLDED. INSTRUCTION FOR USE STATE "DO NOT IMMERSE, ROLL, OR FOLD THE SENSORMAT." PERFORMANCE TESTS WERE PERFORMED AND THE SENSORMAT PAD RETURNED OPERATED ACCORDING TO ALL SPECIFICATIONS. USER DAMAGE TO PLUG WAS FOUND BUT STILL ALLOWED PLUG INSERTION INTO MONITOR FOR TESTING. FACILITY REPORTED THAT THE SENSORMAT PAD WAS OPERATING NORMALLY BEFORE THE EVENT, AND THAT THE SENSORMAT WAS UNPLUGGED FROM THE MONITOR AT THE TIME OF THE EVENT. USER ERROR WAS THE CAUSE OF THE SYSTEM FAILING TO ALARM AS THE SENSORMAT PAD MUST BE PLUGGED INTO A MONITOR TO SOUND AN ALARM.

    Description of Event or Problem · 1

    FACILITY REPORT INDICATES THAT A (B)(6) FEMALE PT SUFFERED A BROKEN TIBIA AND FIBULA AS A RESULT OF A FALL. FACILITY CONTACT WAS NOT SURE WHAT INTERVENTIONS WERE IMPLEMENTED FOR THIS PT AS THE PT HAD BEEN TRANSFERRED TO A DIFFERENT FACILITY. FACILITY CONTACT FURTHER REPORTED ON PERSONAL KNOWLEDGE THAT THE MONITOR AND SENSORMAT PAD WERE WORKING VERY WELL BEFORE THE INCIDENT, AS SHE HAD PERSONALLY ASSISTED THE PT TO THE RESTROOM SEVERAL TIMES AND THE MONITOR ALARMED EVERY TIME. FACILITY'S REPORT INDICATES THAT THE SENSORMAT PAD WAS UNPLUGGED AT THE TIME THE FALL OCCURRED. FACILITY CONTACT STATED THAT THE PAD PLUG HAD BEEN STEPPED ON WHICH EXPLAINED THE DAMAGE TO THE PLUG. FACILITY CONTACT COULD NOT REPORT THE SERIAL NUMBER OR MODEL NUMBER OF THE MONITOR INVOLVED IN THIS INCIDENT. FINALLY, FACILITY CONTACT STATED THAT THEIR DISTRIBUTOR WAS SCHEDULED TO DO INSERVICE TRAINING FOR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED-CHECK ST BED SENSORMAT PAD BED-CHECK SENSORMAT KMI STANLEY SECURITY SOLUTIONS, INC. 74030 A0412

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Other