USER REPORTED THAT HE SUSTAINED A CONTUSION TO HIS LEFT SHOULDER WHEN HE FELL FORWARD APPROX. 16 STEPS WITH THE DEVICE WHILE DESCENDING STADIUM STYLE STAIRS IN SOLO STAIR FUNCTION. USER REPORTED THAT THE DEVICE STARTED TO FALL FORWARD, THEN TURNED TO THE SIDE, ENDING UP ON ITS LEFT SIDE, WHICH IS THE SAME SIDE AS THE REPORTED SHOULDER CONTUSION. USER WENT TO THE ER TO BE EVALUATED. OUTCOME OF X-RAY WAS NEGATIVE FOR FRACTURE / OTHER INJURY, EXCEPT FOR REPORTED CONTUSION, FOR WHICH ORDERS WERE GIVEN TO ICE SHOULDER FOR 24 HOURS AND WARM MASSAGES THEREAFTER. (B)(4).
N
Patient 1
PER NORMAL PROCEDURE, THE CUSTOMER SUPPORT CENTER (CSC) RETRIEVED THE REMOTE SERVICE CODE FROM THE DEVICE WITH THE ASSISTANCE OF THE USER, TO TROUBLESHOOT THE REPORTED EVENT AND HELP DETERMINE IF A MALFUNCTION MAY HAVE OCCURRED. THE RETRIEVED CODE INDICATED THAT THE PITCH LIMIT OF THE DEVICE HAD BEEN EXCEEDED WHILE IN STAIR FUNCTION. THIS IS CONSISTENT WITH THE REPORTED EVENT. NO OTHER INDICATIONS OF A FAULT OR DEVICE MALFUNCTION WERE DETECTED. THE REPORTED EVENT IS CONSISTENT WITH IMPROPER OR INCORRECT TECHNIQUE WHILE STAIR CLIMBING. IN STAIR FUNCTION, THE USER IS AN INTEGRAL COMPONENT OF THE FUNCTION AND MUST MAINTAIN CONTROL OF THE DEVICE IN ORDER TO NEGOTIATE STAIRS. THE CSC ALSO REMINDED THE USER TO BE AWARE OF STEP HEIGHT AND DEPTH WHEN STAIR CLIMBING.