MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3; POWERED WHEELCHAIR

Model Number M3

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

Patient Problem Bone Fracture(s) (1870)

Event Date 06/13/2020

Event Type  Injury  

Manufacturer Narrative

Permobil received report claiming as the end-user was operating their device, it was reported the device having flipped over.Report claims this action caused the end-user to fall out of the seating to the ground resulting in injuries requiring hospitalization.Reports provided claim the end-user suffered unspecified fractures to one of their legs and bones in one of their hands.Reports provided by end-user to service provider claimed the device having lost traction while transitioning down an incline.This loss of traction allegedly allowed the device to become unable to control which allowed it to slide off the pathway and lose upright stability.Device history indicated the suspesion shocks having been recently replaced by the service provider prior to this reported event having occurred.Information received indicates the shocks where adjusted past the maximum setting during replacement which could prevent the suspension from flexing as per design.The device has not been made available for inspection/evaluation at time of this report rendering permobil unable to confirm this as being the root cause.If upon the completion of evaluation any new information is obtained, a follow-up report will be submitted.The dhr was reviewed and device was found to have met specification prior to distribution.

Event Description

Received report claiming while end-user was operating the device in an undisclosed location, the device was reported to have flipped over.Reports indicate the end-user suffered injuries requiring the need for medical intervention.

Manufacturer Narrative

Device was evaluated by permobil representative and service provider finding the device was fully operational both mechanically and electrically.It was confirmed of the device having tendency to lose traction of the drive wheels when transitioning from a level surface to an inclined surface.Inspection of the shock absorbers of the chassis suspension confirmed the maximum tension setting of "c" having been exceeded.The improper tension adjustment was performed by the service provider when installing the shocks, approximately 2 weeks prior to the incident.It was determined the excessive pressure on the spring tension was keeping the suspension from flexing as per design.The shocks were adjusted to the proper setting (b) for the end-user weight, and the device was operationally tested satisfactory with no further loss of traction issues.Service provider has an understanding of the findings and has received instructions to follow manufactures recommended parameters when adjusting shock tension.The device has been returned to the end-user with no further operational issues being reported.The dhr was reviewed and device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL M3
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon, tn
• MDR Report Key: 10271268
• MDR Text Key: 198736769
• Report Number: 1221084-2020-00032
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (y/n): N
• PMA/PMN Number: K123290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 111