MAUDE Adverse Event Report: KI MOBILITY CATALYST 5VX

Model Number	CATALYST 5VX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Still under investigation.It was reported that end user performed diy on the wheelchair after the initial failure without getting the wheelchair properly inspected and repaired.We have not been able to confirm whether maintenance, required in the ifu was performed.User instruction manual (dcn0251.3) states to check all fasteners are tight on a monthly basis.Will file addtional information if it becomes available.
Event or Problem Description
End user stated they lost the hardware for the caster housing and performed home repair.End user did not notify dealer of problem.It is unknown how long the wheelchair was in use before caster fell off.It's unknown as to whether proper maintenance was performed.
Event or Problem Description
End user stated they lost the hardware for the caster housing and performed home repair.End user did not notify dealer of problem.It is unknown how long the wheelchair was in use before caster fell off.It's unknown as to whether proper maintenance was performed.
Additional Manufacturer Narrative
It was reported that end user performed diy on the wheelchair after the initial failure without getting the wheelchair properly inspected and repaired.We have not been able to confirm whether maintenance, required in the ifu, was performed.User instruction manual (dcn0251.3) states to check all fasteners are tight on a monthly basis.Investigation closed.Attempted 5 times to gather more information and no response.

• Brand Name: CATALYST 5VX
• Common Device Name: 5VX
• Manufacturer (Section D): KI MOBILITY; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: kathy wirtz ; 5201 woodward drive; stevens point 54481
• MDR Report Key: 19724676
• Report Number: 3005905321-2024-00003
• Device Sequence Number: 8274817
• Product Code: IOR
• UDI-Device Identifier: 00850013379033
• UDI-Public: (01)00850013379033(11)2022-05-09
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Device Model Number: CATALYST 5VX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male