MAUDE Adverse Event Report: KI MOBILITY, LLC CATALYST 4; MECHANICAL WHEELCHAIR

Model Number	4
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was reported on (b)(6) 2023 stating that the dealer claims the right caster came off of the chair during propulsion.The end user fell down with the chair and suffered mild bruising and pain.It was further reported that it was the right side caster housing bolt and eccentric nut that had fell out."the bottom nut (eccentric nut?) and bolt on the caster assembly fell off and caused the caster to pivot and the chair tipped over with the patient still in the chair." no further information was obtained.
Additional Manufacturer Narrative
This report is being filed out of an abundance of caution due to the residual risk identified in the risk assessment performed on this model and failure mode.If the failure were to reoccur, it could result in more serious injury to a user.

• Brand Name: CATALYST 4
• Common Device Name: MECHANICAL WHEELCHAIR
• 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: 5201 woodward drive; stevens point, WI 54481 ; 8009811540
• MDR Report Key: 16775797
• Report Number: 3005905321-2023-00002
• Device Sequence Number: 6849878
• Product Code: IOR
• UDI-Device Identifier: 00850013379019
• UDI-Public: 00850013379019
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

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: 4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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
• Patient Sex: Unknown