MAUDE Adverse Event Report: KI MOBILITY CATALYST 5VX

Model Number	CATALYST 5VX
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fork/stem assembly came out of the housing while the end user was in the chair, causing him to fall out.It appears the caster housing is missing a component per the photo furnished to us.That component was present at time of final inspection prior to shipping.This appears to be evidence of improper servicing.The housing may have allowed the fork/stem to fall out.The chair has not been made available for inspection.
Additional Manufacturer Narrative
Based on the information that has been provided, it appears someone, other than an authorized supplier (possibly end user or family), worked on the wheelchair because it is missing a component in the photographs.Ki mobility has made multiple attempts to get more information and the suspect parts returned so we can review and determine what may have caused the stated fall.Ki mobility will update this report when the parts are returned or more information becomes available.

• Brand Name: CATALYST 5VX
• Common Device Name: CATALYST
• Manufacturer (Section D): KI MOBILITY; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: kathy wirtz ; 5201 woodward drive; stevens point, WI 54481
• MDR Report Key: 19918760
• Report Number: 3005905321-2024-00007
• Device Sequence Number: 8104126
• Product Code: IOR
• UDI-Device Identifier: 00850013379033
• UDI-Public: (01)00850013379033(11)20240228
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (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: Unknown