MAUDE Adverse Event Report: KI MOBILITY, LLC CATALYST 5; MECHANICAL WHEELCHAIR

Model Number	CATALYST 5
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
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.Based on the information provided, proper maintenance was not carried out in accordance with the ifu and was likely the cause of the event.
Event or Problem Description
A complaint was reported to ki mobility on (b)(6) 2023 stating that a right side nut for the caster housing fell out while the end user was traveling over a threshold in the assisted living facility the end user lives at.The complaint received stated the following, "end user is very active and hits thresholds pretty hard in the home they live in.The end user hit the threshold going into the restroom and the bolt fell out causing the caster housing to break loose.The end user fell to the floor.Was seen by a doctor and is okay with only a bump and a bruise.The facility says they have not provided the chair maintenance to check to see how long the screws have been loose.The incident took place in an assisted living home.".

• Brand Name: CATALYST 5
• 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
• MDR Report Key: 16545846
• Report Number: 3005905321-2023-00001
• Device Sequence Number: 6471979
• Product Code: IOR
• UDI-Device Identifier: 00850013379026
• UDI-Public: 00850013379026
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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: CATALYST 5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown