MalfunctionIOR
CATALYST
Received Apr 16, 2025
Report 3005905321-2025-00003 · MDR key 21848758
Device
Generic name
Catalyst 5
Manufacturer
Ki MobilityProduct problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Concussion
- Concussion
Narrative
Description of Event or Problem
WHEN THE USER WAS LEAVING HOME, USER WAS GOING OVER A DOOR THRESHOLD, WHEN THE ANTI TIP GOT CAUGHT AND CAME OFF, CAUSING THE USER TO FALL BACKWARDS. THE USER LOST CONSCIOUSNESS AFTER RECEIVING A CONCUSSION.
Additional Manufacturer Narrative
WE HAVE REQUESTED THE DEVICE BE RETURNED. WE ARE UNABLE TO VERIFY A DEFECT AT THIS TIME. WILL SUBMIT AN UPDATE IF WE RECEIVE THE PART FOR EVALUATION.