OMNICYCLE ELITE

Description of Event or Problem

FROM THE CUSTOMER: OMNICYCLE ELITE (B)(4) - INVESTIGATION REPORT: DOR SAID, THE BAR THAT STICKS OUT, THE ADJUSTABLE BAR FROM THE UNIT GOT STUCK ON THE PATIENT'S LEG, RESULTING IN DEEP CUT. PATIENT HAD TO GET 36 STITCHES (3 INTERNALLY). ASKED DOR IF THEY CAN SEND A PICTURE OF THE ADJUSTABLE BAR THEY'RE REFERRING TO - DOR SENT A PICTURE OF THE CRANK ARM - THIS IS THE BAR WHERE PATIENT'S PANTS WERE CAUGHT AND INJURED THE MEDIAL SIDE OF HER RLE (PICTURE ATTACHED TO ISSUE NOTE). FROM OUR CLINICAL EVALUATOR: WELL TRAINED AND WELL EXPERIENCED THERAPIST TREATING PATIENT WHOSE PANTS WERE CAUGHT ON THE RADIUS CRANK BAR AND INJURED THE MEDIAL SIDE OF HER RLE REQUIRING HOSPITALIZATION. CPC TRAINING: PLEASE REVIEW OMNICYCLE(R) ELITE MOTORIZED THERAPEUTIC EXERCISE SYSTEM USER MANUAL (REVISED 12/08/2020 PART NO. 290A000533 REV 9) INCLUDING WARNINGS, PRECAUTIONS AND SET & OPERATIONS INCLUDING PG. 16 SECTION CALF SUPPORTS:"THE CALF SUPPORTS HELP TO SECURE THE LEGS IN CASES OF PARALYSIS. THEY ARE CONNECTED TO THE FOOTRESTS BY A PIVOTING JOINT SO AS NOT TO IMPAIR MOVEMENT OF THE ANKLES. ADJUST THE HEIGHT OF THE CALF SUPPORTS SO THAT THE CUPS FIT AROUND THE CALVES. SECURE THE LEGS WITH THE VELCRO(R) STRAPS. MAKE SURE ANY LOOSE-FITTING CLOTHING IS SECURED WITH THE CALF SUPPORT VELCRO(R) STRAP SO IT DOES NOT CATCH IN THE SPINNING ASSEMBLIES DURING LOWER EXTREMITY EXERCISE." CUSTOMER DATA: (B)(6) PERSON REPORTING COMPLAINT: (B)(6) IN ADDITION, THE OMNICYCLE HAS WARNING STICKERS ON THE PEDALS THAT ALERT USERS TO THE IMPORTANCE OF SECURING LOOSE CLOTHING.