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

Model Number F5 CORPUS VS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 02/13/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 311372492
• Report Number: 1221084-2023-00003
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose