MAUDE Adverse Event Report: KI MOBILITY, LLC KI; CATALYST 5VX

Model Number	CATALYST 5VX
Medical Device Problem Codes	Mechanical Problem (1384); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: KI
• Common Device Name: CATALYST 5VX
• Manufacturer (Section D): KI MOBILITY, LLC; 5201 woodward drive; stevens point 54481
• Manufacturer (Section G): KI MOBILITY, LLC; 5201 woodward drive; stevens point 54481
• Manufacturer Contact: nancy elliott ; 5201 woodward drive; stevens point 54481 ; 7155441784
• MDR Report Key: 24381745
• Report Number: 3005905321-2026-00003
• Device Sequence Number: 10257549
• Product Code: IOR
• UDI-Device Identifier: 00850013379033
• UDI-Public: 00850013379033
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K062660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CATALYST 5VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 100 KG