inforMED
MalfunctionIOR

CATALYST

Received Apr 16, 2025

Report 3005905321-2025-00003 · MDR key 21848758

Device

Generic name

Catalyst 5

Manufacturer

Ki Mobility

Product 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.