CATALYST 5
Received Apr 5, 2024 · Event occurred Jul 23, 2023
Report 3005905321-2024-00001 · MDR key 19051397
Device
Generic name
Manual Wheelchair
Manufacturer
Ki MobilityProduct problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Male
- Unspecified Musculoskeletal problem
- Insufficient Information
- Unspecified Musculoskeletal problem
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THERE IS INSUFFICIENT INFORMATION TO VERIFY COMPONENT FAILURE. THIS APPEARS TO BE MISUSE BASED ON THE IFUS. EITHER THERE WAS POOR MAINTENANCE AND INSPECTION OR FAILURE TO FOLLOW INSTRUCTIONS FOR REMOVING AND INSTALLING THE REAR WHEEL. (B)(6) SECTION T. WHEELS INSTALLTION & REMOVAL. THERE ARE WARNINGS AND INSTRUCTIONS FOR THE PROPER METHOD FOR THE REMOVAL AND REATTACHMENT OF REAR WHEEL. THERE ARE ALSO WARNINGS AND INSTRUCTIONS FOR PROPER INSPECTION AND MAINTENANCE OF THE COMPONENTS.
Description of Event or Problem
END USER INJURED RIGHT SHOULD AFTER FALLING FROM THE CHAIR AND WAS TAKEN TO THE HOSPITAL. END USER CLAIMED THAT THE FALL WAS THE RESULT OF THE REAR WHEEL DETACHING FROM THE FRAME. FURTHYERMORE THE END USER REPORT THAT THIS HAS HAPPENED MULTIPLE TIMES, BUT DID NOT REPORT ANY OTHER ADVERSE EVENTS. THESE EVENTS WERE NOT REPORTED TO KI UNTIL (B)(6), 2024
Additional Manufacturer Narrative
IT HAS BEEN CONFIRMED THERE IS NO DEVICE FAILURE. THIS APPEARS TO BE MISUSE BASED ON THE IFUS. EITHER THERE WAS POOR MAINTENANCE AND INSPECTION OR FAILURE TO FOLLOW INSTRUCTIONS FOR REMOVING AND INSTALLING THE REAR WHEEL. DCN0082.9 SECTION T. WHEELS INSTALLATION & REMOVAL. THERE ARE WARNINGS AND INSTRUCTIONS FOR THE PROPER METHOD FOR THE REMOVAL AND REATTACHMENT OF REAR WHEEL. THERE ARE ALSO WARNINGS AND INSTRUCTIONS FOR PROPER INSPECTION AND MAINTENANCE OF THE COMPONENTS.
Description of Event or Problem
END USER INJURED RIGHT SHOULD AFTER FALLING FROM THE CHAIR AND WAS TAKEN TO THE HOSPITAL. END USER CLAIMED THAT THE FALL WAS THE RESULT OF THE REAR WHEEL DETACHING FROM THE FRAME. FURTHERMORE, THE END USER REPORTED THAT THIS HAS HAPPENED MULTIPLE TIMES, BUT DID NOT REPORT ANY OTHER ADVERSE EVENTS. THESE EVENTS WERE NOT REPORTED TO KI UNTIL (B)(6) 2024