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

Model Number F5 CORPUS VS

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

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

Event Date 01/28/2024

Event Type  Injury  

Manufacturer Narrative

The end-user claims as they were operating their device, the device reportedly started driving by itself and the end-user did not have the ability to stop or course correct via the joystick controller.This action reportedly forced the device to collide into a railroad track bed, resulting with the end-user being ejected from the seating and sustaining injuries requiring medical intervention.Reports indicate the end-user sustained broken ribs as a result of the fall.Interviews with the end-user were limited due to the end-user reporting having no memory of the event.Device was returned to permobil germany for inspection.Reports indicate the device was received in an inoperable state, with signs of physical damages.Permobil was unable to discern if the noted damages where the result of the event, or had been inflicted prior to the event over the course of the devices 7 years of use.Permobil was unable to confirm the reported malfunction of "unintended movement" due to the condition of the device upon receipt.Permobil germany will continue to investigate, and 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 specifications prior to distribution.

Event Description

Permobil ab received a report claiming while the end-user was operating their wheelchair out-of-doors, reported that the wheelchair started driving on its own causing the end-user to lose control.This sudden start reportedly caused them to crash into a track bed resulting in injuries requiring medical intervention to address.

• Brand Name: PERMOBIL F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB; per uddens väg 20; timrå, S-861 23; SW S-86123
• Manufacturer (Section G): PERMOBIL AB; per uddens väg 20; timrå, S-861 23; SW S-86123
• Manufacturer Contact: anna-karin wahlström ; per uddens väg 20; timrå, S-861-23 ; SW S-86123
• MDR Report Key: 18876623
• MDR Text Key: 337345518
• Report Number: 1221084-2024-00004
• Device Sequence Number: 1
• Product Code: IPL
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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