inforMED
MalfunctionIOR

KI

Received Feb 18, 2026 · Event occurred Nov 24, 2024

Report 3005905321-2026-00004 · MDR key 24382098

Device

Generic name

Catalyst 5vx

Manufacturer

Ki Mobility, Llc

Model number

CATALYST 5VX

Product problems

  • Naturally Worn
  • Damaged Thread

Patient

66 YR · Female

  • Bone Fracture(s)

Narrative

Description of Event or Problem

WHEEL LOCK DISENGAGED DURING PATIENT TRANSFER FROM CHAIR TO BED BECAUSE ONE OF THE WHEEL LOCK BOLTS WORKED ITS WAY OUT. BRAKE BOLT WORKED ITS WAY OUT WHILE HUSBAND WAS TRYING TO MOVE CLIENT FROM CHAIR TO BED. HUSBAND WENT TO SEAT PATIENT IN CHAIR TO GET A BETTER HOLD THEN WHEEL LOCK DISENGAGED AND CHAIR ROLLED AWAY. BOTH PATIENT AND HUSBAND FELL TO FLOOR. PATIENT COMPLAINED OF DISCOMFORT IN LEGS. END USER WAS TAKEN TO GET AN MRI WHERE THEY DISCOVERED HER LEG WAS BROKEN. END USER DID NOT COMPLAIN OF ANY PAIN/INJURY. ON 11/25 USER WENT TO PT APPOINTMENT, IT WAS SUGGUESTED THAT USER GET X-RAYS, AND THAT SHOWED BOTH LEGS TO BE FRACTURED.

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 AND IT WAS DETERMINED THAT THE CUSTOMER MODIFIED THE WHEELLOCK HARDWARE. THE USER MANUAL STATES THE PROPER MAINTENANCE AND SCHEDULE FOR HARDWARE.