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 Code	Concussion (2192)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report indicating while the end-user was on a vehicle platform lift, they inadvertently drove the wheelchair to the edge of the platform where the metal safety barrier reportedly gave way allowing the wheelchair and end-user to fall approx.3' to the ground.This event resulted in injuries requiring medical intervention to address.
Additional Manufacturer Narrative
Report claims while the end-user was on a vehicle platform lift, they inadvertently drove the wheelchair to the edge of the platform where the metal safety barrier reportedly gave way allowing the wheelchair and end-user to fall approx.3' to the ground.This event reportedly occurred in the hospital parking lot, and the end-user was brought in for examination where they were diagnosed as having sustained a concussion.Inspection of the device noted some physical damages to components having occurred that are being attributed to the impact during the event.No claims or allegations were made of the device having malfunctioned in any way to have contributed to this event, with the dealer and end-user laying causation of the lift outer barrier having failed to stop the device from going off the edge.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• 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: 20843254
• Report Number: 1221084-2024-00022
• Device Sequence Number: 8100086
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/04/2024

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: 11/05/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2021
• 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: Prefer Not To Disclose