BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABS PROFESSIONAL

    MDR report key: 3202289 · Received June 28, 2013

    Report

    Report Number
    1929691-2013-00006
    Event Type
    Death
    Date Received
    June 28, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 28, 2013
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL #: (B)(4). NO ITEMS OF VISUAL DAMAGE NOTED. BED PAD RETURNED DID NOT SHOW SIGNS OF CREASING OR IMPROPER USE, BUT THE CORD AND CORD PLUG SHOWED SOME EVIDENCE OF BEING PULLED CONSISTENT WITH USE. MONITOR AND PAD WERE FULLY FUNCTIONALLY TESTED, WITH NO FAILURES OR NON-CONFORMITIES NOTED. A SEPARATE BATTERY WAS RETURNED, WHICH WAS DESCRIBED BY THE FACILITY AS THE BATTERY THAT HAD BEEN IN THE MONITOR AT THE TIME OF THE INCIDENT, THIS BATTERY'S VOLTAGE TESTED AT 7.88 V, ABOVE THE LOW BATTERY THRESHOLD FOR THREE MONITORS. SYSTEM FUNCTIONED NORMALLY, NO FAILURES COULD BE REPRODUCED. NO NON-CONFORMITIES NOTED.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT SHORTLY AFTER A MEDICATION NURSE HAD GIVEN THE RESIDENT MEDICATIONS IN THE EARLY MORNING, A CNA PASSED BY THE ROOM AND OBSERVED THE RESIDENT DOWN ON THE FLOOR, AND REPORTED NO TABS ALARM WAS SOUNDING. RESIDENT SUFFERED A SUBDURAL HEMATOMA AND WAS TAKEN TO THE HOSPITAL. FACILITY CONFIRMED THAT THE TABS MONITOR WAS WORKING THE NIGHT BEFORE THE INCIDENT, AND WAS ALSO FOUND TO OPERATE PROPERLY UPON TESTING CONDUCTED AFTER THE INCIDENT. FACILITY REPORTED THAT THE RESIDENT EXPIRED ON OR ABOUT (B)(6) 2013 AS A RESULT OF THE SUBDURAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295278 TABS PROFESSIONAL MONITOR, BED PT KMI STANLEY SECURITY SOLUTIONS, INC. 25023; 26550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death