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); Multiple Fractures (4519)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

The end-user reported as they were attending a physical therapy session at the local college, while in the device in a standing position, the chest strap used to secure their upper torso become undone.This reportedly caused the end-user to lose positioning of their upper body, allowing them to fall forward out of the seating.The end-user reported their legs remained restrained by the knee block assembly and the subsequent fall forward resulted in a bi-lateral fracture to their tibia's.The end-user claimed they did not incorporate the chest bar provided with the device, but had been using a chest harness provided by a third party instead.The end-user reported the strap being used at the time of the event was installed that day by one of the staff at the therapy center, and it is their belief that they did not properly secure it at the buckle, and it became loose and disconnected.The end-user stated the device did not malfunction in any way to have contributed to this event, but was more an oversight on their part for not ensuring the proper protective restraints were in place before engaging the seating in standing protocols.The dhr was reviewed and the device was found to have met specification prior to distribution.

Event Description

Received reports claiming while end-user was performing a stand function, the chest strap being used to keep them in the seating detached allowing the client to lose positioning and fall forward.Reports having sustained serious injury as a result.

• 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: 12187416
• MDR Text Key: 262158756
• Report Number: 1221084-2021-00023
• Device Sequence Number: 1
• Product Code: ITI
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2021

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
• 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
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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 Weight: 70