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

Model Number	F3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Collision (1429); Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report as the end-user was turning the device inside an elevator, the device reportedly turned too far causing end-user to strike foot against the wall resulting in an injury requiring medical attention.
Additional Manufacturer Narrative
Report received indicates while the end-user was entering an elevator and performing a turn face the chair to the doorway, the end-user claims when attempting to stop the turn by releasing the joystick, the device continued to turn allowing their foot to strike the doorway opening.This contact reportedly caused the end-user to sustain a broken metatarsal.Inspection of the device was conducted by the service provider who reported not finding any operational issues.Device was reported to be fully responsive, and they were unable to replicate the continued drive/failure to stop as described by the end-user.As device was found to be fully operational with no signs of mechanical or electrical malfunctions having occurred, and no reports of recurring behavior, permobil unable to reach a determination as to probable root cause without speculation.Permobil will continue to monitor, and 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 15702059
• Report Number: 1221084-2022-00020
• Device Sequence Number: 15017306
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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: 10/06/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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