MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL C500 CORPUS; POWERED WHEELCHAIR

Model Number F3

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)

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

Event Date 07/04/2022

Event Type  Injury  

Event Description

Permobil ab received report of while end-user was attempting to transfer from their power wheelchair to the toilet, the device reportedly turned on and drove.This had led to the end-users leg being pinched between the wheelchair and the wall resulting in an injury requiring medical intervention.

Manufacturer Narrative

Reports claim as the end-user was in process of transferring to the toilet, the device allegedly turned itself on and initiated a drive command causing the wheelchair to hit the end-user's leg and pinch them between the wall and the wheelchair.This action reportedly resulted in the end-user having sustained a fracture to their tibia.The device was evaluated by the local service technician who reported not having found any abnormalities with the device or components.Device was found to remain fully operational with no indications of mechanical or electrical issues.Technician was unable to duplicate the involuntary activation as alleged, therefore was unable to determine a root cause of the event without speculation.If any new information is received, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL C500 CORPUS
• 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 86123
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 15527213
• MDR Text Key: 301004880
• Report Number: 1221084-2022-00018
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K991658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2013
• 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