Description of Event or Problem · 1
DESCRIPTION OF DEVICE: A VESTIBULAR/BALANCE TESTING ROTATIONAL CHAIR WAS PURCHASED IN 2007. AFTER INSTALLATION OF THE CHAIR, IN COLLABORATION WITH THE MANUFACTURER, MODIFICATIONS WERE MADE TO THE SOFTWARE / HARDWARE FOR AN ADDITIONAL CLINICAL TESTING PROTOCOL. THE CHAIR CAME PROGRAMMED WITH SEVERAL PROTOCOL OPTIONS. NEWER MACHINES NOW INCLUDE HARDWARE THAT DOES REQUIRE THE MODIFICATIONS MADE AT THIS FACILITY AS A STANDARD OPTION. ADDITIONALLY, WITH MANUFACTURER KNOWLEDGE, A KNEE STRAP WAS DEVELOPED WHICH COULD BE SECURED TO THE CHAIR. THE CHAIR IS STANDARD WITH A FOUR POINT CHEST RESTRAINT AND FOOT GUARDS. THE FOUR POINT RESTRAINT, KNEE STRAP AND FOOT GUARDS ARE UTILIZED TO SECURE A PATIENT IN THE CHAIR.EVENT:PATIENT IN NEUROKINETICS ROTATIONAL CHAIR FOR VESTIBULAR/BALANCE TESTING. STAFF HAD SECURED THE FOUR POINT CHEST RESTRAINT CORRECTLY. THE KNEE STRAP AND THE FOOT RETENTION SYSTEMS WERE NOT UTILIZED. DURING THE TEST THE PATIENT SLID DOWN IN THE CHAIR AND ATTEMPTED TO REMOVE THE FOUR POINT CHEST RESTRAINT. PATIENT WAS CHOKED BY THE FOUR POINT UPPER STRAP, LOST CONSCIOUSNESS AND WAS PROJECTED TO THE FLOOR BY THE SPINNING MOTION OF THE CHAIR. PATIENT ASSESSED AND ADMITTED TO THE HOSPITAL FOR MULTIPLE LACERATIONS, BACK AND RIB FRACTURES, PAIN. THE MANUFACTURER WAS CONTACTED REGARDING THE EVENT. INTERNAL DISCUSSIONS ENSUED REGARDING NEED FOR ENHANCED SAFETY FEATURES WITH AUTO-STOP MAGNETIC SENSORS IF RESTRAINT/STRAPS ARE NOT SECURED. THE MANUFACTURER IS BEING CONTACTED REGARDING PARTICIPATION IN THIS TYPE OF MODIFICATION. MANUFACTURER STATED THEY FILED REPORT WITH FDA. THE MANUFACTURE PERFORMED THE ROUTINE MAINTENANCE CHECK ON THE EQUIPMENT THREE DAYS AFTER THE EVENT (PRE-SCHEDULED). SYSTEM WAS IN NORMAL WORKING ORDER.