inforMED
MalfunctionIOR

KI

Received Feb 18, 2026 · Event occurred Oct 1, 2024

Report 3005905321-2026-00003 · MDR key 24381745

Device

Generic name

Catalyst 5vx

Manufacturer

Ki Mobility, Llc

Model number

CATALYST 5VX

Product problems

  • Mechanical Problem
  • Patient Device Interaction Problem

Patient

41 YR · Male

  • Bone Fracture(s)

Narrative

Description of Event or Problem

DEALER CLAIMS THAT THE END USER WAS TRANSFERRING OUT OF THE CHAIR AND THE ARMREST RECEIVER FELL OUT AND THE END USER FELL AND BROKE 2 RIBS. DEALER STATED THAT THEY HAD BEEN OUT 5 TIMES FOR MAINTENANCE AND TIGHTENED THE HARDWARE FOR THE ARMREST RECEIVERS. IT HAPPENED ON 10/24 AT THE END USER'S HOME.

Additional Manufacturer Narrative

AFTER RETROSPECTIVE REVIEW OF COMPLAINTS, THIS REPORT WILL BE FILED IN ABUNDANCE OF CAUTION BECAUSE RECORD WAS NOT REPORTED. NO ADDITIONAL INFORMATION OR COMMUNICATION WITH THE END USER AFTER THE INITIAL REPORT. REPLACEMENT PARTS WERE PROVIDED. RETURNED PRODUCT WAS EVALUATED WITH NO ROOT CAUSE IDENTIFIED.