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

Model Number	F3
Medical Device Problem Codes	Mechanical Problem (1384); Device Tipped Over (2589); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Permobil was served with a lawsuit on behalf of the deceased end-user's estate.The lawsuit alleges that the end-user was descending a portable ramp outside his sister's residence when the device tipped over forward and crushed him.The end-user was taken to the local hospital where he succumbed to undisclosed injuries and died the following day.The legal complaint alleges that the fault for the event was due to the device not having "anti tippers/support wheels" installed on the device at distribution from manufacturing or having been removed prior to distribution to the end-user and failure to warn of possible harm if not installed.There are no other claims or allegations of any other product malfunction having occurred.A review of device history was conducted, and it was noted that the device was configured and shipped with the front support wheels installed.Review of device photos at shipping confirms the device was shipped with the front support wheels installed.It remains unclear when the front support wheels were removed as claimed or by whom.At this time, permobil has not been provided with any information as to the length of the portable ramp, nor the height of rise the ramp was being used in order to calculate the angle of decent at the time of the incident.The device manual warns users not to drive the wheelchair on slopes steeper than 10° and to use caution on slopes steeper than 6°.The device manual also states that support wheels must not be removed if equipped at manufacture.Permobil will continue with the investigation, and if any new information is received, a follow-up report will be submitted.
Event or Problem Description
Received report claiming that the end-user was maneuvering their f3 corpus down a portable ramp from a residence when the device tipped over forward and landed atop the end-user.This reportedly resulted in serious injuries eventually leading to death the following day.

• 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: 25318964
• Report Number: 1221084-2026-00007
• Device Sequence Number: 14769218
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: (01)17330818676433(11)240424
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: Death
• Patient Sex: Unknown