MAUDE Adverse Event Report: KI MOBILITY, LLC KI; ROGUE ALX

Model Number	ROGUE ALX
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dealer claims the left caster housing is rotating under the chair.Has been loose since they got the chair, dealer and user have had to constantly tighten it.End user stated the left caster mount and housing rotated backwards under the chair causing the user to fall forward out of the chair.User broke his ankle and foot.Happened at the end user's home.End user was trying to transfer onto his stair lift when the left housing rotated under his chair which made the chair fall forward.He could have fallen down the stairs but instead fell onto his left leg and foot.
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 part were provided.Complaint investigation report - risk analysis.The data suggests the device was used outside of intended use: the caster housing was reported loose upon receipt of the chair.Multiple attempts to tighten the caster mount failed, yet the dealer allowed use of the chair.The user fell forward out of hte chair after multiple failed attempts to tighten the bolts.Justification for acceptance of residual risk: all materials have a failure point if subjected to over-stressing and misuse of varying degrees, making an inherently safe design impossible.Tesing in compliance with applicable harmonized standards provides a protective measure by demonstrating strength and durability, thus minimizing the risk of the hazardous situation of component failure.Instruction for proper use and warning against misuse in the owner's manual are the only further actions that can be taken to minimize risk.Risk is reduced as far possible.

• Brand Name: KI
• Common Device Name: ROGUE ALX
• 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: 24382374
• Report Number: 3005905321-2026-00005
• Device Sequence Number: 10622561
• Product Code: IOR
• UDI-Device Identifier: 00850013379316
• UDI-Public: 00850013379316
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: ROGUE ALX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 64 KG