MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5 CORPUS; POWERED WHEELCHAIR

Model Number	F5 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Report received while end-user was driving their f5 corpus, the footplates hit the ground which caused a sudden stoppage of the device.This reportedly caused the end-user to lose positioning and fall from the seating to the ground, resulting in an injury requiring medical intervention to address.
Additional Manufacturer Narrative
Service provider reported the end-user was driving their device, when suddenly the footplate assembly slid down and contacted the ground.This action reportedly stopped the forward momentum of the wheelchair which caused the end-user to lose positioning and fall from the seating to the ground.The provider stated that the end-user received injuries requiring them to be hospitalized, and admitted into an icu, but was not forthcoming as to extent of injuries sustained.The reporting provider conducted an inspection, indicating a previous service activity as not being performed correctly in that the hardware that secures the footplates to the leg tube appears to have been improperly secured.The provider deduced it was this improper securement that allowed the footplates to slide down and subsequently jam into the ground, stopping the device.No claims or allegations were made of a component, or product malfunction, related to design or manufacturing, having occurred to have contributed to this event.The dhr was reviewed, and the device was found to have met specifications prior to distribution.

• Brand Name: PERMOBIL F5 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: 18818261
• Report Number: 1221084-2024-00002
• Device Sequence Number: 8169887
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143014
• 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): 03/01/2024

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: F5 CORPUS
• 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: 02/07/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2021
• 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