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

Model Number	F3 CORPUS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user reported they had been having instances where the switchbox for seat functions would go dark for a moment and come back on.This reportedly made the end-user feel that the device may quit on them, and they chose to transfer into a back-up device for an upcoming medical appointment.During the transfer, the end-user described having lost balance and fallen backwards and injured themselves to where they were diagnosed as having sustained a concussion.Permobil representative inspected the device, and with the end-user operating, was unable to reproduce the reported flickering of the switchbox lights.The device was found to remain fully operational with no signs of an electrical failure having occurred.The end-user made comment to permobil that the device never had failed, only that they felt it may have failed and they did not want to take a chance while out of doors.The end-user did not claim a device malfunction caused the event, only that if the device did not have the reported issue of flickering lights, they would not have transferred thus would not have fallen.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming as the end-user was transferring from their power wheelchair to another device, they reported to have lost their balance and fell backwards on to the floor where they sustained an injury requiring medical intervention to address.

• Brand Name: PERMOBIL F3 CORPUS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 22797467
• Report Number: 1221084-2025-00010
• Device Sequence Number: 12902513
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: (01)17330818676433(11)250605
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 07/18/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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
• Patient Sex: Unknown