BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMP

    MDR report key: 4990443 · Received August 3, 2015

    Report

    Report Number
    1929691-2015-00003
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    May 14, 2015
    Report Date
    August 4, 2015
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PAD AND MONITOR OPERATED NORMALLY UPON FUNCTIONAL TESTING. AS REC'D, THE MONITOR WAS SET TO "RE ONLY" WHICH ONLY ALLOWS ALARM RESET ON USE OF INFRARED RESET FOB. THERE WAS NO TACTILE FEEDBACK ON THE RIGHT RESET BUTTON, BUT UPON CHANGING SETTING TO "RE/LOCAL" RESET BUTTONS WERE FOUND TO OPERATE NORMALLY. PAD WAS SHIPPED/REC'D FLAT BUT THERE WAS EVIDENCE OF MINOR FOLDING. PAD OPERATED NORMALLY AND NO OTHER DEFECTS WERE NOTED. ALARM FAILURE COULD NOT BE DUPLICATED UPON TESTING, AND NO DEFECTS WERE NOTED. MFR SUSPECTS THAT MONITOR WAS NOT PROPERLY ARMED, AND THEREFORE DID NOT ALARM.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE FACILITY THE DAY BEFORE THE EVENT. THE NIGHT OF THE EVENT (EARLY A.M.) THE PATIENT WAS NOTED TO HAVE GOTTEN UP TO USE THE RESTROOM, AND FACILITY INVESTIGATION INDICATED THAT THE FALL MONITOR SOUNDED AT THAT TIME. THE PATIENT REPORTEDLY GOT UP AGAIN A LITTLE LATER, AND THE ALARM REPORTEDLY DID NOT SOUND. THE PATIENT FELL, SUFFERING A FRACTURED CLAVICLE THAT DID NOT REQUIRE SURGERY TO REPAIR (REPORTED THAT AN ARM SLING WAS REQUIRED). FACILITY STATED THAT THE MONITOR/PAD SETUP WAS TESTED SHORTLY AFTER THE INCIDENT, VIA HAND PRESSURE TESTING AND THE MONITOR WAS REPORTED TO BE WORKING CORRECTLY AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505678 UMP BED-PATIENT MONITOR KMI STANLEY SECURITY SOLUTIONS, INC. 91621; 92020 E0711; B0914

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other