MAUDE Adverse Event Report: PERMOBIL AB PERMOBIL F3 CORPUS; POWERED WHEELCHAIR

Model Number F3 CORPUS

Device Problems Mechanical Problem (1384); Device Tipped Over (2589); Unintended Movement (3026)

Patient Problem Concussion (2192)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

Information received thus far claims the device was being used on a pedestrian/bike path, which was described as "very steep" incline.The report claims while traversing this inclined terrain, one of the drive wheels started spinning, as if losing traction, and described the power wheelchair starting to slide backwards where report claims the device tipped over.Reports indicate the end-user sought medical intervention after the event where they were diagnosed as having sustained a concussion.At the time of this report, the power wheelchair has yet to be evaluated, therefore a determination as to probable root cause cannot be established without speculation.An evaluation has been scheduled with the end-user, and when 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.

Event Description

Permobil ab, in sweden, received a report claiming as the end-user was driving their device up a steep pedestrian/bike pathway, it was reported one of the drive wheels began to spin and the device started to slide backwards.Reports claim this caused the device to lose upward stability and tip over.This event was reported to have resulted in an injury requiring medical intervention.

Manufacturer Narrative

New information indicates the end-user has recuperated with no remedial medical intervention required.Service provider assessed the device and reported to find it fully operational with no signs of a malfunction having occurred.Inspection of the event site showed the path as being at a 22° inclined grade consisting of asphalt and gravel.The end-user described the event as having nearly reached the top of the inclined grade, when one of the drive wheels lost traction and began to spin.This forced the device to shift off to the side of the grade, into the softer dirt, where the device started sliding backwards until it impacted an immovable large rock.This sudden stop and angle of descent allowed for the device to lose upright stability and fall over backwards.With the information provided, permobil is considering this as an extraordinary event not related to a device malfunction or use error.

• Brand Name: PERMOBIL F3 CORPUS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB; 20 per uddens vag; timra, S-861 23; SW S-86123
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: anna-karin wahlstrom ; 20 per uddens vag; timra,, TN
• MDR Report Key: 16771143
• MDR Text Key: 313600038
• Report Number: 1221084-2023-00007
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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: 05/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2019
• 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