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

Model Number	CATALYST 5VX
Medical Device Problem Codes	Naturally Worn (2988); Damaged Thread (4075)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: KI
• Common Device Name: CATALYST 5VX
• Manufacturer (Section D): KI MOBILITY, LLC; 5201 woodward drive; stevens point WI 54481
• Manufacturer (Section G): KI MOBILITY, LLC; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: nancy elliott ; 5201 woodward drive; stevens point, WI 54481 ; 7155441784
• MDR Report Key: 24382098
• Report Number: 3005905321-2026-00004
• Device Sequence Number: 21488369
• Product Code: IOR
• UDI-Device Identifier: 00850013379033
• UDI-Public: 00850013379033
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CATALYST 5VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 79 KG