MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3 CORPUS; POWERED WHEELCHAIR

Model Number	F3 CORPUS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report indicates one of the nurses put the chair in manual/freewheel mode and maneuvered the device out of the residence and made a 90-degree turn to manually push the 600-lb chair & end-user down a steep ramp.Report claims the nurse lost control of the wheelchair and inadvertently ran the end-user into an object, subsequently fracturing the right tibia.Permobil representative and dealer inspected the device finding it to be fully operational and no claims nor allegations were made of a failure having occurred with the device for which this event could be attributed.Permobil rep and dealer test drove the device, with end-user, utilizing the installed attendant controls.The device was reported to be tracking straight with no abnormalities being found.Further training was conducted with all caregivers on the proper use of the attendant controls and instruction provided that when placing the device into freewheel mode, it should only be performed on level ground as outlined in the owner's manual.The dhr was reviewed, and device was found to have met specification prior to distribution.
Event or Problem Description
Received report of a caregiver having placed the device in to freewheel and attempted to maneuver the device, with end-user, down a ramp manually.Reports indicate the caregiver lost control of the device causing the end-users right leg to impact an immovable object resulting in an injury requiring medical intervention.

• Brand Name: PERMOBIL F3 CORPUS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 12417711
• Report Number: 1221084-2021-00031
• Device Sequence Number: 19928032
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: F3 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 94