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

Model Number	F3
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report claiming while end-user was driving their device through a school hallway, the device reportedly lost power coming to an abrupt stop.The sudden stop reportedly resulted with the end-user sustaining serious injuries requiring medical intervention to address.
Additional Manufacturer Narrative
Report provided indicated as the end-user was traveling down the hallway of their school, the joystick went completely dark and the chair stopped suddenly.The end-user was reported to be wearing a positioning belt, and when the chair stopped suddenly, the momentum caused the end-user to fall forward.The end-user is diagnosed with osteogenesis imperfecta, and with the positioning belt in place it reportedly resulted in multiple fractures to include a fractured femur requiring surgery to address.The provider reported having inspected the chair and was unable to identify any loose connections with any of the cabling or battery connections.Reported the chair powered up normally and were unable to reproduce a loss of power as reported to have occurred.The end-user reported to the provider that just after the incident, the device powered up normally when pressing the power button on the joystick controller.No further reports have been received from the family of recurring behavior since the event.Review of system messages did not indicate any errors having occurred to which the reported loss of power could be attributed.With the information provided, permobil is unable to reach a determination as to possible root cause without speculation.Review of dhr indicates the device having met specification prior to distribution.

• Brand Name: PERMOBIL F3
• 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: 24547114
• Report Number: 1221084-2026-00002
• Device Sequence Number: 15799278
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: (01)17330818676433(11)250225
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/09/2026

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
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown