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

Model Number	F3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Device Tipped Over (2589); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user described the situation as while exiting their motor vehicle via the incorporated ramp, when they let go of the jsm to stop, claims the chair continued to roll and the device went off the side of the ramp which allowed the device to lose upright stability and fall over on to its side.The end-user reported having sustained an undisclosed injury to the foot which required medical intervention, and the need for an air cast to immobilize.Permobil representative and provider evaluated the device and did not find any irregularities with the wheelchairs performance or how it stops.It was observed that when the end-user exits their vehicle, they "back-down" the ramp as opposed to facing forward, and the end-user voiced concerns with how sensitive the controls were.Some adjustments were made to the electronics to better meet the end-users needs and capabilities.It was recommended to the end-user that best practice is to always face forward when operating a wheelchair while on a ramp to have better visibility where the device is positioned.Permobil is unable to confirm a product malfunction having occurred, therefore is unable to determine a root cause for this event without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming as end-user was exiting a motor vehicle via a ramp, when releasing the jsm to stop, alleges the device continued to roll which allowed a wheel to fall off the ramps edge causing it to lose stability where it fell over on to its side resulting in an injury to the end-user that required medical intervention.

• 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 16469116
• Report Number: 1221084-2023-00002
• Device Sequence Number: 18086339
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/02/2023

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: 02/10/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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: Prefer Not To Disclose