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

Model Number	F5 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Device Tipped Over (2589); Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report of while the end-user was stopped in front of a restaurant entrance, the f5 corpus device reportedly started driving in reverse with no touching of joystick.This reportedly resulted in the device's caster wheels dropping off a curb edge which allowed the device to lose stability and fall to the side resulting in injury to the end-user.
Additional Manufacturer Narrative
Report claims the device reportedly went into reverse without the end-user having engaged with the joystick control.This action allowed one of the rear caster wheels to drop off a curb edge forcing the device to become unstable and fall to the side.This resulted in an injury to the end-user having sustained a hairline fracture to their right ulna.Device was evaluated by permobil representative and was found to remain fully operational with no indications of a product malfunction having occurred.End-user mentioned having a toddler in their lap when the event occurred, but did not recall if the joystick was inadvertently moved by the infant.After a full evaluation, and review of the circumstances surrounding the reported event, permobil is unable to reach a determination as to root cause of the event without speculation.The dhr was reviewed, and the device was found to have met specification 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: 19497296
• Report Number: 1221084-2024-00009
• Device Sequence Number: 7870464
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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: Prefer Not To Disclose