BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABS

    MDR report key: 2804854 · Received October 25, 2012

    Report

    Report Number
    1929691-2012-00008
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MANUFACTURER AS FACILITY REPORT INDICATES THAT DEVICE OPERATED NORMALLY BOTH DURING AND AFTER THE INCIDENT. ADDITIONALLY, FACILITY WAS UNABLE TO PROVIDE SERIAL AND LOT NUMBER INFO FOR THE EQUIPMENT INVOLVED. THE PAD IN USE WAS DISCARDED, AND THE MONITOR IN USE WAS PLACED BACK IN SERVICE AFTER THE INCIDENT SINCE NO PRODUCT MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT A PT WAS BEING MONITORED BY TABS SYSTEM IN A CHAIR USING A CHAIR PAD. THE RESIDENT "SCOOTED" FORWARD IN THE CHAIR WHILE KEEPING WEIGHT ON THE PAD, THEN ATTEMPTED TO GET UP UNASSISTED. THE RESIDENT FELL AND SUFFERED A BROKEN HIP, REQUIRING SURGICAL REPAIR. FACILITY REPORTED THAT TABS SYSTEM ALARMED IMMEDIATELY, BUT THAT DUE TO THE WAY THE FALL OCCURRED, STAFF STILL FOUND THE PT DOWN ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TABS TABS PROFESSIONAL KMI STANLEY SECURITY SOLUTIONS, INC. 25222; 26201 FAC. DID NOT REPORT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention