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

Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The wheelchair components were not returned yet so we could determine if the components were defective.This is the initial report and we will update when the parts are returned and evaluated to determine if the component was defective or if it is a maintenance issue.
Event or Problem Description
Wheel lock disegnaged during patient transfer from chair to bed because some of the bolts/hardware worked it's way out.Brake bolt worked it's way out while husband was trying to move user from chair to bed.Husband seated user in chair to get a better hold of wheel lock.Then wheel lock disengaged, and chair rolled away.
Additional Manufacturer Narrative
The part was returned and reviewed.The part appeared adulterated.No defect found.The user manual dcn0251 rev 7 states to inspect wheel lock for engagement and for adjustments weekly.The user manual also states check all fasteners are tight on a monthly basis.
Event or Problem Description
Wheel lock disegnaged during patient transfer from chair to bed because some of the bolts/hardware worked it's way out.Brake bolt worked it's way out while husband was trying to move user from chair to bed.Husband seated user in chair to get a better hold of wheel lock.Then wheel lock disengaged, and chair rolled away.

• Brand Name: CATALYST
• Common Device Name: CATALYST 5VX
• Manufacturer (Section D): KI MOBILITY; 5201 woodward drive; stevens point WI 54494
• Manufacturer Contact: kathy wirtz ; 5201 woodward drive; stevens point, WI 54481
• MDR Report Key: 20988767
• Report Number: 3005905321-2024-00009
• Device Sequence Number: 7846128
• Product Code: IOR
• UDI-Device Identifier: 00850013379033
• UDI-Public: (01)00850013379033(11)2024-10-24
• 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: Other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female