BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED-CHECK CLASSIC-CHECK MONITOR

    MDR report key: 2739914 · Received September 11, 2012

    Report

    Report Number
    1929691-2012-00006
    Event Type
    Injury
    Date Received
    September 11, 2012
    Report Date
    August 30, 2012
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY REPORTED THAT THE SENSORMAT PAD IN USE AT THE TIME OF THE INCIDENT WAS THROWN AWAY BY STAFF, AND THE STAFF HAS NOW BEEN INSTRUCTED TO KEEP ALL ACCESSORIES INVOLVED IF ANY FUTURE INCIDENTS OCCUR. FACILITY'S REPORT INDICATES THAT STAFF CLAIMED THE UNIT FAILED TO ALARM, AND THAT THE MONITOR WAS SENT TO THEIR BIO-MED DEPARTMENT FOR EVALUATION. ON BIO-MED'S EVALUATION OF THE MONITOR, NO FAILURES TO ALARM COULD BE REPRODUCED, AND BIO-MED'S REPORT INDICATES THAT BOTH THE LOCAL ALARM AND THE NURSE CALL OUTPUT OF THE MONITOR SIGNALED ALARMS. FACILITY ALSO REPORTED THE SERIAL NUMBER OF THE MONITOR INVOLVED IN THIS INCIDENT AS (B)(4). AT THE TIME OF THIS REPORT, THE USER FACILITY HAS NOT RETURNED THE MONITOR INVOLVED IN THIS INCIDENT FOR MANUFACTURER'S EVALUATION. FACILITY'S REPORT INDICATES THAT UNIT OPERATED NORMALLY POST-INCIDENT, SO MANUFACTURER SUSPECTS USER ERROR. HOWEVER, NO CONCLUSIONS CAN BE DRAWN WITHOUT AN EVALUATION OF THE MONITOR IN QUESTION.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT THE PT IN THIS CASE WAS CONFUSED AND REPEATEDLY TRYING TO GET OUT OF BED. AT THAT TIME, FACILITY STAFF REPORTED THAT THE ALARM WAS OPERATING PROPERLY, BUT ONE TO ONE MONITORING WAS STILL NEEDED, SO A STAFF MEMBER WAS ASSIGNED TO SIT IN THE ROOM WITH THE PT. FACILITY REPORTED THAT DURING THIS ONE TO ONE TIME, THE STAFF MEMBER RECALLED THAT THE ALARM DID NOT SOUND WHEN HELPING THE RESIDENT TO READJUST IN BED, BUT DIDN'T THINK TO MUCH OF IT AS THE PT WAS BEING PERSONALLY MONITORED. THE STAFF MEMBER THEN LEFT THE ROOM FOR A SHORT PERIOD OF TIME, AND HEARD THE "THUMP" FROM THE PT FALLING. THE PATIENT WAS REPORTED AS SUFFERING A FRACTURED HIP FROM THE FALL. STAFF THEN REPLACED THE MONITOR, BUT LEFT THE SENSORMAT PAD IN USE, AND STAFF REPORTED THAT THE SYSTEM OPERATED CORRECTLY AT THAT TIME. THE SENSORMAT PAD WAS LATER THROWN OUT AS THE FACILITY USES MATS FOR SINGLE PT USE. FACILITY HAS AT THE TIME OF THIS REPORT BEEN UNWILLING TO RETURN THE MONITOR TO THE MANUFACTURER FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention