Description of Event or Problem · 0
ON 2025-01-28, MOTION COMPOSITES WAS INFORMED BY A CLIENT VIA EMAIL OF AN INCIDENT INVOLVING THE HELIO A6 WHEELCHAIR, SERIAL NUMBER (B)(6). THE REPORTING PERSON'S MOTHER, THE PATIENT, WAS THE INDIVIDUAL INVOLVED IN THE INCIDENT. ACCORDING TO THE INFORMATION AVAILABLE, THE PATIENT DID NOT NOTICE THAT ONE OF THE WHEEL LOCKS ON THE WHEELCHAIR WAS BROKEN. THE INCIDENT OCCURRED DURING A TRANSFER, WHEN THE PATIENT FELL AND SUSTAINED AN INJURY, RESULTING IN A BROKEN FEMUR. THE PATIENT WAS SUBSEQUENTLY TREATED AT THE (B)(6) HOSPITAL IN (B)(6), ON (B)(6) 2025, WHERE A PER-PROSTHETIC FEMUR FRACTURE WAS DIAGNOSED. SHE WENT TO THE OPERATION ROOM ON (B)(6) 2025. THE PATIENT IS DESCRIBED AS BEING 5 FEET 5 INCHES TALL AND WEIGHING 215 POUNDS. THE CLIENT INDICATED THAT THE FAILURE OF THE PUSH-TO-LOCK MECHANISM WAS NOTICED PRIOR TO THE FALL, BUT NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE SPECIFIC CAUSE OF THE FALL ITSELF. REPLACEMENT PUSH-TO-LOCK PARTS WERE PROVIDED FROM THE MANUFACTURE UNDER WARRANTY, SENT ON 2025-02-13. FOR REFERENCE, THE WHEELCHAIR WAS MANUFACTURED ON 2023-02-22. THIS IS THE FIRST REPORTED ADVERSE EVENT FOLLOWING FAILURE OF THE NEWTON PUSH-TO-LOCK ITEM (PART NUMBERS 41076C-00 & 41077C-00). AS OF 2025-02-24, MOTION COMPOSITES IS AWAITING CONFIRMATION FROM OUR DISTRIBUTOR REGARDING THE RETURN OF THE PARTS FOR FURTHER EXAMINATION. FOR REFERENCE, IN MOTION COMPOSITES 0070757C-00 USER MANUAL FOLDING WHEELCHAIRS, DATE OF ISSUE (B)(6) 2021, REVISION DATE (B)(6) 2022, THE FOLLOWING WARNINGS ARE SPECIFIED: P.13 SECTION 6.4.4 TRANSFERRING ¿ ROTATE THE CASTERS FORWARD TO ENHANCE THE STABILITY OF THE CHAIR. ¿ PLACE THE WHEELCHAIR AS CLOSE TO YOUR TRANSFER LOCATION AS POSSIBLE. ¿ ENGAGE WHEEL LOCKS. ¿ POSITION YOURSELF AS FAR BACK AS POSSIBLE WHEN TRANSFERRING WEIGHT TO REDUCE THE RISK OF TIPPING FORWARD. IF YOU HAVE GOOD UPPER BODY STRENGTH, BALANCE AND AGILITY, YOU MAY BE ABLE TO PERFORM TRANSFERS INDEPENDENTLY. - IF AT ALL POSSIBLE, MOVE THE FOOTREST IN A POSITION THAT WILL AVOID PUTTING WEIGHT ON IT. IF POSSIBLE, USE A TRANSFER BOARD. P.16 WHEEL LOCKS WARNINGS NEVER USE WHEEL LOCKS TO SLOW OR STOP WHEELCHAIR MOVEMENT. WHEEL LOCKS ARE NOT BRAKES. MAKE SURE THE SURFACE IS NOT SLIPPERY AS THE WHEELCHAIR COULD MOVE EVEN THOUGH THE WHEEL LOCKS ARE ENGAGED. MAKE SURE THE STEM LOCKS EMBED AT LEAST 3 MM WHEN THEY ARE ENGAGED. THE TIRE MUST BE INFLATED PROPERLY. MAKE SURE THE WHEELCHAIR IS STABLE AND FULLY LOCKED BEFORE WHEEL LOCKS ARE ENGAGED. ¿ TO ENGAGE THE LOCKS, PUSH THE WHEEL LOCK HANDLE FORWARD (FOR PUSH-TO-LOCK TYPE) OR PULL WHEEL LOCK BACKWARD (FOR PULL-TO-LOCK TYPE) UNTIL THE LOCK IS FULLY ENGAGED AND THATP.30 SECTION 11. PERIODIC CHECKLIST: AT EVERY USE ¿ MAKE SURE WHEEL LOCKS ARE WORKING PROPERLY.