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

Model Number	LIBERTY
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
While the chair was being tilted, the end user's finger was injured by being pinched near the wheel lock.End user's hand was in the area of the frame/wheel lock when being tilted.Alleged event occurred at (b)(6) facility during rehab.As part of the investigation, it was determined that the owner's manual includes warnings of the pinch points in question and was provided to the end users' caregiver at delivery of the wheelchair.
Additional Manufacturer Narrative
An incident occurred on (b)(6) 2022 that resulted in a compression of the distal phalanges when the patients finger was trapped between the bumper, seat frame and the seat frame or between the bumper, seat frame mount and seat frame during tilt positioning.Due to the severity of the alleged incident, this report is being filed while the investigation is underway.
Event or Problem Description
While the chair was being tilted, the end user's finger was injured by being pinched near the wheel lock.End user's hand was in the area of the frame/wheel lock when being tilted.Alleged event occurred at (b)(6) facility during rehab.As part of the investigation, it was determined that the owner's manual includes warnings of the pinch points in question and was provided to the end users' caregiver at delivery of the wheelchair.
Additional Manufacturer Narrative
It was determined by the investigation of this adverse event that additional pinch point labeling was needed to warn users of an originally unrecognized potential hazard.An eco was initiated, two additional pinch point labels were added to the device, and additional pinch point warnings were added to the owner's manual for the device.

• Brand Name: LIBERTY
• 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 dr.; stevens point WI 54481
• Manufacturer Contact: 5201 woodward dr.; stevens point, WI 54481 ; 8009811540
• MDR Report Key: 15970335
• Report Number: 3005905321-2022-00001
• Device Sequence Number: 5107185
• Product Code: IOR
• UDI-Device Identifier: 00850013379125
• UDI-Public: 00850013379125
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: LIBERTY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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: Hospitalization; Disability
• Patient Sex: Male