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

Model Number F5 CORPUS VS

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Reports provided indicate the event was caused by unintended actions made by the end-user where they inadvertently depressed a seat function button which initiated the seating to go into a standing position.It was reported at the time of this action occurred, the end-user did not have the necessary supports such as knee block and chest roll bar installed which are required to be in place whenever a stand function is performed.Without having any supports in place, the standing action allowed the end-user to lose their positioning in the seating and fall forward to the floor.Reports claim the end-user's feet were secured to the footplate with straps and when falling forward resulted in the end-user suffering a fracture to their lower leg and shin.The end-user claims they had gotten their fingers caught between the end of the armrest and the seat function control box and inadvertently engaged the stand function and was unable to remove their hand before the resulting event occurred.The device was evaluated by the local service provider and was found to be fully operational.Permobil has provided recommendations of various configuration changes that could be made in efforts to meet the clients use needs, but to mitigate any chance for unintended activation.The dhr was reviewed and the device was found to have met specification prior to distribution.

Event Description

Reports while end-user was seated in their device, they inadvertently initiated a stand function without having any of the necessary body supports in place.This action caused the end-user to lose positioning and fall out of the seating to the ground resulting in injuries requiring medical intervention.

• Brand Name: F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 86102 3; SW 861023
• Manufacturer (Section G): PERMOBIL AB; per uddens vag 20; timra, 861 2 3; SW 861 23
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, tn ; 7360925451
• MDR Report Key: 10265048
• MDR Text Key: 199083864
• Report Number: 1221084-2020-00033
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/13/2020

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: 06/16/2020
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1