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

Model Number	F3 CORPUS
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	09/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Report received stating as end-user was driving at speed down a sidewalk, the device reportedly lost power and came to an abrupt stop.This reportedly allowed the end-user to lose positioning and fall from the seating to the ground where they sustained injuries requiring medical intervention.
Additional Manufacturer Narrative
Report claims as the end-user was traversing at speed down a sidewalk, the device reportedly lost power and stopped.Report indicates the end-user was not wearing the incorporated positioning belt, and the forward momentum allowed the end-user to lose upright positioning and fall from the seating.Report indicates the end-user was taken to a local er where x-rays were negative, but later it was determined having sustained bi-lateral hairline fractures to the tibias.Report claims the device was operational after the event but was presenting a system code indicating a cable error.Local service technicians inspected the device and could not find any signs of a product malfunction having occurred.The event reportedly occurred 1 month prior to receiving the report, and the device reportedly has been in service since the event with no further issues.With the information provided, and the device having been found to remain fully operational.Permobil is unable to reach a determination as to possible root cause without speculation.If any new information is received, a follow-up report will be submitted.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: 20642505
• Report Number: 1221084-2024-00020
• Device Sequence Number: 15311519
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: 10/16/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2022
• 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: Male