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

Model Number	F5 CORPUS VS
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report claiming as the end-user was placed into a stand position, the chest support nor pelvic positioning belt where installed.The knee block was in place and when end-user reached an upright position, they fell forward hanging over the front of the chair.This event resulted in a serious injury requiring medical intervention.
Additional Manufacturer Narrative
Witness accounts claim the end-user's caregiver forgot to install the chest bar and pelvic positioning belt while the end-user was seated in the device, but they did install the knee block assembly.Reports indicate the caregiver left the room, and in their absence the end-user reportedly initiated a stand function without the protective components in place.When reaching a stood position, the end-user lost positioning in the seating and fell forward.Reports indicate when this occurred, the end-user sustained bi-lateral fractures to their tibias.No claims or allegations were made that the device malfunctioned or deviated in any way to have contributed to this event.Reports indicate the caregiver was new and was unfamiliar with the standing wheelchair and the protocols for safe operation.The permobil representative advised the family and end-user to not attempt any standing protocals without first receiving medical clearance, and recommended when they are medically cleared they should go back to the wheelchair clinic to ensure no adjustments/modifications need to be made.The dhr was reviewed and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL F5 CORPUS VS
• 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: 14163505
• Report Number: 1221084-2022-00008
• Device Sequence Number: 5795960
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191874
• 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): 04/20/2022

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: F5 CORPUS VS
• 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: 03/24/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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