BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED-CHECK IT BED SENSORMAT

    MDR report key: 2809975 · Received October 18, 2012

    Report

    Report Number
    1929691-2012-00009
    Event Type
    Death
    Date Received
    October 18, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 18, 2012
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN INCIDENT WAS NOT RETURNED TO MFR FOR EVAL DUE TO FACILITY'S REFUSAL TO SEND IT. FACILITY TESTED A SENSORMAT PAD FROM THE SAME LOT AS THE INCIDENT PAD AND REPORTED A DELAYED ALARM ON THIS TEST. FACILITY'S DESCRIPTION OF THE TESTING CONDUCTED RAISED QUESTIONS OF PROPER TESTING, AS A PT LIFT WAS USED TO REMOVE WEIGHT FROM THE SENSORMAT PAD, AND THE FACILITY REPORTED THAT, AFTER THE DELAYED ALARM, A STAFF MEMBER PASSED ON THE PAD AND IT THEN ALARMED. BASED ON THIS REPORT, MFR SUSPECTS, BUT CANNOT CONFIRM, THAT SENSORMAT PAD WAS NOT PROPERLY ALARMED DURING THE TEST. SENSORMAT PAD WAS INVOLVED IN INCIDENT, BUT FROM SAME PRODUCTION LOT, WAS RETURNED TO MFR FOR EVAL. VISUAL INSPECTION COMPLETED WITH NO MAJOR USER DAMAGE OR MFG DEFECTS NOTED. PAD WAS FUNCTIONALLY TESTED AND OPERATED ACCORDING TO SPECIFICATIONS. PAD WAS ALSO SUBJECTED TO IMPEDANCE TESTING BY ENGINEERING AND IT WAS NOTED THAT THE PAD COULD BE FORCED INTO AN OPEN CIRCUIT BY TWISTING THE PAD CORD. ULTIMATELY, IT WAS DETERMINED THAT THIS CONDITION WAS THE RESULT OF EXCESS RTV SEALANT USED IN MFG. THIS CONDITION IS DETERMINED TO BE UNRELATED TO THE REPORTED DELAYED ALARM, AND DID NOT INTERFERE WITH PROPER OPERATION. BECAUSE THE ACTUAL DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR A MFR'S EVAL, NO CONCLUSION COULD BE DRAW WITH RESPECT TO THE REPORTED INCIDENT. BASED ON THE FACILITY'S REPORT OF A PILLOW ON THE SENSORMAT PAD POST-INCIDENT, AND THE FACILITY'S FAILURE TO USE RUBBER BANDS AND CLIPS TO SECURE SENSORMAT PAD, MFR SUGGESTS THAT PILLOW MAY HAVE BEEN WEDGED AND KEPT WEIGHT ON THE PAD. FACILITY HAS BEEN UNABLE TO CONFIRM WHETHER OR NOT THIS OCCURRED.

    Description of Event or Problem · 1

    PT WAS FOUND ON THE FLOOR BY FACILITY STAFF AND FACILITY STAFF STATED THAT BED-CHECK SYSTEM WAS NOT ALARMING. THE PT WAS ASSESSED AFTER THE FALL PER HOSPITAL PROCEDURES; NO PHYSICAL DAMAGE TO THE PT WAS OBSERVED, BUT THE PT DID COMPLAIN OF A HEADACHE. THE PT WAS SCHEDULED FOR A CAT SCAN, BUT THE PT EXPIRED BEFORE THE CAT SCAN COULD BE CONDUCTED, APPROX 1 HOUR AFTER THE INCIDENT. FACILITY FURTHER REPORTED THAT DURING THE PT'S ASSESSMENT, IT WAS NOTED THAT A PILLOW WAS ON THE SENSORMAT PAD. WHEN THE PILLOW WAS REMOVED, THE SYSTEM SIGNALED AN ALARM. FACILITY WAS UNABLE TO REPORT WHETHER THE PILLOW WAS WEDGED BY THE BED AND PLACING WEIGHT ON THE SENSORMAT PAD. FACILITY ADDITIONALLY REPORTED THAT RUBBER BANDS AND CLIPS WERE NOT USED TO SECURE THE SENSORMAT PAD IN PLACE. FACILITY ALSO REPORTED TESTING A NON-INCIDENT PAD OF THE SAME TYPE, MODEL, AND LOT NUMBER AFTER THE EVENT. THE SYSTEM WAS SET UP WITH A STAFF MEMBER IN THE BED, AND A GULDMAN'S BRAND PT LIFT WAS USED TO LIFT THE STAFF MEMBER OFF THE SENSORMAT PAD. ON THIS TEST, STAFF REPORTED A 12-SECOND PERIOD WITH NO ALARM, THEN A STAFF MEMBER PRESSED ON THE PAD AND THE SYSTEM ALARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED-CHECK IT BED SENSORMAT SENSORMAT KMI STANLEY SECURITY SOLUTIONS, INC. 74000 H0312

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death