BEUDAMED
    FDA Adverse Event Other Summary report: N

    9VCTAD TFH VECTA DISTRACTION UNIT

    MDR report key: 1501231 · Received September 30, 2009

    Report

    Report Number
    MW5012934
    Event Type
    Other
    Date Received
    September 30, 2009
    Report Date
    September 30, 2009
    Manufacturer
    TFH -USA- LTD
    Product Code
    MQN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLEASE BE ADVISED THAT WE PURCHASED A TFH VECTA DISTRACTION UNIT FROM TFH -USA- LTD, AFTER THE COMPANY MARKETED THE PRODUCT -INCLUDING NAMING OTHER INSTITUTIONS. AFTER ARRIVAL, WE HAD THE UNIT CAREFULLY AND THROUGHLY INSPECTED BY OUR INSTITUTION'S SAFETY ENGINEERS AND FOUND THE FOLLOWING ISSUES: THE UNIT UTILIZES A COMPILATION OF DIFFERENT MANUFACTURED SYSTEMS, INCLUDING A LIGHT PROJECTOR, CAR STEREO, AN AURA FAN UNIT, A LIGHT AMPLIFIER FOR FIBER OPTICS, AND AN ELECTRIC PUMP TO MOVE WATER. THE CONCERN WE HAVE IS THAT THESE SYSTEMS WERE NOT MADE WITH THE INTENT TO USE IN A HOSPITAL ENVIRONMENT AND DO NOT COMPLY WITH REQUIREMENTS FOR USE IN AN IN-PT HOSPITAL SETTINGS. AS A RESULT, SOME OF THE DEVICES DO NOT MEET NECESSARY SAFETY CODES, INCLUDING LACK OF GROUNDED CONDUCTORS WITH HOSP GRADE PLUGS. MULTIPLE FLEXIBLE CORDS ARE CONNECTED TO A CENTRAL PLUG STRIP RATHER THAN DIRECTLY WIRED AS ONE UNIT. PLUGGING OTHER ITEMS INTO THE PLUG STRIP MEANS ACTIVE FLOW OF ELECTRICITY WHEN PLUGGED OR UNPLUGGED RESULTING IN SPARK/ARC CREATION. THESE CORDS ARE TIED TOGETHER AND ANCHORED TO THE CART OF THE UNIT WITH A ZIP TIE, CREATING STRESS ON THE CORDS, AND AS SUCH, IN NONCOMPLIANCE WITH STANDARDS RESTRICTING ANCHORAGE OF FLEXIBLE CORDS. YOUR COMPANY, AS MFR, STATES THE VECTA UNIT CANNOT BE USED WHERE AN "INTRICICLY" SAFE DEVICE IS REQUIRED AND THE PLUG CONTAINS A WRITTEN WARNING STATING IT MAY NOT MEET HOSP REQUIREMENTS. THE USE OF SOME OF THE FRAGRANCES PROVIDED WITH THE UNIT, INCLUDING EUCALYPTUS, ROSEMARY, ETC., ARE STRONG SENSITIZERS TO SOME PEOPLE AND COULD CREATE A PROBLEM FOR PEDIATRIC PTS AND THERE ARE NO ASSURANCES THAT THE USE OF THESE FRAGRANCES HAVE BEEN REVIEWED BY A PEDIATRIC ALLERGIST OR PULMONOLOGIST. GIVEN THE ABOVE OBSERVATIONS, WE RECOGNIZE THE POTENTIAL HAZARDS AND NON-COMPLIANCE POSED BY THE DEVICE FOR USE IN AN HOSP SETTING AND WE ATTEMPTED TO DISCUSS THIS MATTER WITH THE COMPANY PRESIDENT. WE WERE TOLD THAT THE 90 DAY REFUND TIME HAD EXPIRED, BUT WE COULD GET A STORE CREDIT, BUT WOULD HAVE TO PAY ALL SHIPPING/FREIGHT COSTS. THE ISSUES WE BROUGHT FORWARD REGARDING SAFETY CODES AND CONCERNS WERE DISREGARDED BY THE COMPANY WHO STATED IN A LETTER DATED SEPTEMBER 23, 2009, "THIS UNIT IS USED EXTENSIVELY." WE FEEL THIS UNIT IS A RISK DUE TO ITS FAILURE TO MEET MULTIPLE STANDARDS AND THEREFORE, REPRESENTS THE POTENTIAL INCREASED RISK TO OUR PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9VCTAD TFH VECTA DISTRACTION UNIT TFH VECTA UNIT MQN TFH -USA- LTD 9VCTAD

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other