MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL F5 CORPUS VS; POWERED WHEELCHAIR

Model Number F5 CORPUS VS

Device Problem Use of Device Problem (1670)

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

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Interviews conducted with the end-user and caregiver indicate the caregiver drove the wheelchair into an elevator compartment utilizing the co-pilot attendant control.With the lift being relatively small, they had to drive diagonally and into the corners of the elevator to give space to the wheelchair and prevent end-user's feet to hit the wall.In addition, the assistant must position themself on far-left side of the wheelchair then fold the co-pilot handle to allow the lift door to be closed.When entering the elevator on the day of the event, the caregiver reportedly kept their hand on the co-pilot control handle, with device remaining under power, when suddenly the chair moved towards the caregiver impacting their right leg.Reports indicate due to the impact; the caregiver sustained a fracture to their right tibia.The service provider reports their inspection of the device after the event did not show any indications of a device malfunction having occurred, finding the device fully functional with no operational abnormalities.With the testimony provided, and inability to confirm a product malfunction having occurred.Permobil (b)(4) has determined this event was the result of inadvertent use error, by caregiver, for failing to adhere to proper operational guidelines as outlined in the co-pilot user manual.The dhr was reviewed, and device was found to have met specification, prior to distribution.

Event Description

Received report claiming while an attendant was maneuvering the wheelchair into an elevator, utilizing the co-pilot attendant control, the attendant became squeezed between the wheelchair and the elevator wall resulting in an injury to the attendant requiring medical intervention.

• Brand Name: PERMOBIL F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 86123 ; SW 86123
• MDR Report Key: 12529162
• MDR Text Key: 273762501
• Report Number: 1221084-2021-00033
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• 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: 08/30/2021
• 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