BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABS

    MDR report key: 2415143 · Received December 21, 2011

    Report

    Report Number
    1929691-2011-00014
    Event Type
    Injury
    Date Received
    December 21, 2011
    Date of Event
    November 4, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/7/2011, (B)(4) RECEIVED A TABS PROFESSIONAL MONITOR MODEL # 25223, A TABS DISPOSABLE PT SPECIFIC PAD MODEL # 26300, AND NURSE CALL "Y" ADAPTOR P/N 0707-421. USER FACILITY REQUESTED THAT ALL ITEMS BE RETURNED FOR QUARANTINE AND FURTHER INVESTIGATION. DURING INSPECTION/TESTING OF THE PRODUCTS, (B)(4) FOUND THE FOLLOWING: THE PRODUCT WAS TESTED OPERATIONALLY AND PERFORMED ACCORDING TO MFR'S SPECS. MONITOR ALARMED PROPERLY AND OUTPUT SIGNAL WAS FOUND THROUGH NURSE CALL ADAPTOR. COMPLAINT WAS OF THE MONITOR NOT ALARMING THROUGH THE NURSE CALL SYSTEM TO THE RN'S PHONE. (B)(4) IS UNABLE TO EVALUATE THE NURSE CALL SYSTEM, AND IS NOT THE MFR OF THE RAWLAND NURSE CALL SYSTEM ASSOCIATED WITH THIS EVENT. ALTHOUGH THE NURSE CALL ADAPTOR FUNCTIONED ACCORDING TO MFR'S SPECS, ONE OF THE PLUG MOUNTS WAS RETURNED LOOSE FROM THE OUTER HOUSING. (B)(4) COULD NOT REPLICATE A FAILURE OR INTERMITTENT FAILURE OF THE ADAPTOR TO TRANSMIT AN ALARM SIGNAL. STANLEY INFORMED CUSTOMER NOT TO PUT NURSE CALL ADAPTOR BACK INTO SERVICE BECAUSE OF DAMAGE TO THE PLUG. DISPOSABLE PT SPECIFIC PAD WAS RETURNED TO (B)(4) FOLDED, WHICH MAY CAUSE IMPROPER FUNCTIONING OF THE PAD. CUSTOMER WAS INFORMED NOT TO PUT THE PAD BACK INTO SERVICE DUE TO THE OBSERVED FOLD.

    Description of Event or Problem · 1

    A (B)(6) PT WITH A HISTORY OF FALLS WAS ASSESSED AT HIGH RISK TO FALL AS WELL AS HIGH RISK FOR INJURY; TABS BED ALARM PLACED ON BED FROM DAY OF ADMISSION TO MEDICAL UNIT ON (B)(6) 2011. ON (B)(6) 2011, THE PT FELL IN THE HALLWAY ON THE MEDICAL UNIT; PT SUSTAINED RIGHT FEMORAL NECK FRACTURE FROM THE FALL. RN REPORTED TABS BED ALARM DID NOT ALARM TO HER PHONE TO ALERT HER THAT THE PT WAS ATTEMPTING TO GET OUT OF BED. THE PT WAS TAKEN TO THE OPERATING ROOM (B)(6) 2011 FOR HEMIARTHROPLASTY OF HIS RIGHT HIP; PT TOLERATED PROCEDURE WELL AND WAS DISCHARGED TO A SHORT TERM REHABILITATION FACILITY (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TABS TABS PROFESSIONAL KMI STANLEY SECURITY SOLUTIONS, INC. 25223

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| S