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

Model Number	F5 CORPUS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported to have occurred over 1 year prior, and permobil was not made aware at time of occurrence.Report indicates the device was powered up, and while end-user leaned forward to pick up some glasses that had fallen, inadvertently contacted the joystick knob (trigger), which caused the device to move.This action reportedly caused the end-user to lose balance and fall out of the seating.Report indicated the end-user is an btk amputee and they reportedly landed on their stump which resulted in an fx to their hip.No claims or allegations were made of a device malfunction having occurred that would have contributed to this event.Review of device history does not indicate any reports or service requests in/around the timeline the event was reported to have occurred.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Reports while leaning forward in seating to pick up their glasses, the end-user inadvertently hit the "trigger" which caused the device to move allowing the end-user to lose positioning and fall out of seating resulting in an injury.

• 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: 20176118
• Report Number: 1221084-2024-00016
• Device Sequence Number: 8261268
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/09/2024

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: 08/19/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2021
• 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