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

Model Number	F5 CORPUS VS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information provided to permobil indicated as the end-user was performing a stand function in their f5 corpus vs, the chest bar was reported to have come loose which allowed the end-user to lose upright positioning and fall forward.Report indicates the end-user had their legs secured with a knee block, and when falling forward they sustained bi-lateral fractures to left and right tibias/fibulas requiring surgery to address.Further interviews with the end-user indicate the incident was caused by not ensuring the chest bar was properly installed and secured before initiating a stand function.The end-user reported the chest bar was inserted into one of the receivers, but the opposing side was not secured, resting in front of the receiver.When they leaned against the chest bar, it rotated out of the way allowing the end-user to lose stability of their upper torso.The end-user claims the device did not malfunction and was solely an oversite on their part.The device was evaluated and found to remain fully operational with no mechanical issues being noted.The dhr was reviewed with device being found to have met specification prior to distribution.
Event or Problem Description
Received report claiming as the end-user was performing a stand function, the chest bar came loose which allowed the end-user to fall forwards out of the seating.This resulted in an injury requiring medical intervention.

• 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: 16551518
• Report Number: 1221084-2023-00003
• Device Sequence Number: 19559880
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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: 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: 02/21/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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