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)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports indicate the end-user is near or over the max weight limit of 330lbs, with reports indicating weight fluctuations from 315 - 350lbs, and the user reporting using the tilt feature numerous times throughout the day.The service provider had attempted to address the tilt over current issue by replacing the tilt motor, but after a short period of time the over current error returned which leaves the end-user unable to perform tilt.According to the end-user, without the ability to tilt they are unable to pressure relief, and this is causing them to develop pressure injuries around their groin area.Reports indicate the end-user has a history of pressure ulcers and this issue is exacerbating their existing wounds.Although it was confirmed a component malfunction having occurred, permobil is unable to confirm the root cause without speculation.Permobil representative is in discussion with the service provider regarding the end-user's weight, and if they can work with the end-user and payor source to provide a device that is better suited to meet the demands for the end-user's weight fluctuation.
Event or Problem Description
Reports tilt function on their device was receiving over current errors rendering the tilt function to be inoperable.This prevented the end-user from performing proper pressure relief which reportedly led to the development of pressure injuries requiring medical intervention to address.

• 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: 25153643
• Report Number: 1221084-2026-00006
• Device Sequence Number: 9351961
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: (01)17330818676433(11)240617
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 04/14/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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: Other
• Patient Sex: Unknown