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

Model Number F3 CORPUS

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Concussion (2192); Multiple Fractures (4519)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Report provided claims the left uni-track rail on the seating had detached which caused the end-user to lose balance and fall to the ground where they sustained serious injuries requiring medical intervention (fx femur, fx arm, concussion).Reports provided from family described the end-user having positioned themselves towards the front of the seat pan to provide access to a portable male urinal.It was described that the end-user utilizes the thigh support, which is mounted to the front edge of the seating, to stabilize themselves during this process.Reports claim as the end-user was in this process, the hardware that secures the uni-track rail to the seating had broken which allowed the thigh support to fall away.Reports indicate the end-user's father installed new hardware and discarded the affected hardware prior to permobil's awareness of this event.Without being able to inspect the hardware, permobil is unable to determine if there was a product deficiency.With information provided of clients use habits of utilizing the thigh support for weight bearing; permobil has determined this failure was most likely the result of inadvertent use error by utilizing components from which they were not intended, which overtime resulted in undue stresses to hardware leading to material fatigue.The dhr was reviewed, and the device was found to have met specification prior to distribution.

Event Description

Reports while using a portable urinal, the end-user was utilizing the thigh support as a weight bearing surface to stabilize themselves.Reports claim the left uni-track rail having detached, claiming mounting hardware having broken, which resulted in the end-user losing their balance and falling from the seating.

• Brand Name: PERMOBIL F3 CORPUS
• 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: 15606346
• MDR Text Key: 301736917
• Report Number: 1221084-2022-00019
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143180
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F3 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• 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