Description of Event or Problem · 1
THE TSA-II (MODEL 2001) IS 510(K) APPROVED (K922052). THE TSA-II APPLIED HOT AND COLD STIMULATION, AND ALLOWS PARTICIPANTS TO CLICK A BUTTON WHEN THEY FEEL THAT STIMULATION. THE MACHINE HEATS AND COOLS A COOLANT, PUSHES IT INTO A "THERMODE" THAT IS HELD TO THEIR SKIN, AND THE PARTICIPANT IS INSTRUCTED TO CLICK A BUTTON WHEN THEY FEEL THE STIMULATION MEET A SPECIFIC REQUIREMENTS DEFINED BY THE ASSESSOR. FOR EXAMPLE, IN ONE TEST, WE MIGHT INSTRUCT THE PARTICIPANT TO CLICK THE BUTTON WHEN THEY FEEL THE STIMULATION JUST STARTING TO HURT, AS IF THEY ARE TOUCHING AN ICE CUBE OR POPSICLE. THE COMPUTER THEN RECORDS THE TEMPERATURE DELIVERED WHEN THE BUTTON WAS PUSHED. THE MACHINE IS INTENDED TO BE CALIBRATED EITHER EVERY SIX MONTHS, OR EVERY YEAR, DEPENDING ON WHICH VERSION OF THE MFR MANUAL IS BEING REFERENCED. USING A NIST CERTIFIED INFRARED THERMOMETER TO MEASURE THE TEMPERATURE BEING RADIATED BY THE THERMODE DEVICE, AND UNDER NORMAL TESTING CONDITIONS, WE CONSISTENTLY RECORDED THREE SEPARATE DEVICES ALL PUTTING OUT TEMPERATURES WHICH WERE INACCURATE FROM THOSE REPORTED BY THE DEVICE COMPUTER. ADDITIONALLY, WE NOTED THAT THE DEVICES CONSISTENTLY DELIVERED STIMULATION WHICH EXCEEDED THE THRESHOLD FOR SAFETY OF ZERO DEGREES CENTIGRADE. WE RECORDED TEMPERATURE BELOW ZERO DEGREES CELSIUS, AND THERE IS ACADEMIC LITERATURE SHOWING THAT THIS POSES A RISK OF FROSTBITE. THE ISSUES WE HAVE DEMONSTRATED SHOW THAT: THE DEVICE POSES A SAFETY RISK; THE DEVICE TAKES INACCURATE MEASUREMENTS OF TEMPERATURE. FDA SAFETY REPORT ID# (B)(4).