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

Model Number	M3
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user described having leaned forward in the seating to reach for something on their kitchen counter.It was during this action that the footplates reportedly fell downward which allowed the end-user to lose their balance and fall out of the seating.The subsequent fall reportedly resulted in a radial fracture to the left tibia and fibula, necessitating medical intervention to address.Review of client file, and confirmation from end-user indicates the leg rest assembly not having received any routine service since device had been distributed over 5 years prior.The service provider reported having inspected the device and found the web belt, that secures the foot plate assembly to the leg rest for articulation during elevation, having severed.Further inspection shown the linkage designed to keep tension on the web belt having developed sharp edges on the sides of the roller.It is being determined the cause for the belt failure was sharp edge of roller, having developed over time, causing cuts in the belt material which eventually lead to material fatigue.The device has been repaired with new components, and re-delivered to the end-user.The dhr was reviewed, and the device was found to have met specifications prior to distribution.
Event or Problem Description
While the end-user was in their kitchen and reaching forward to gather something off the counter, the footplate assembly reportedly dropped down which caused the end-user to lose positioning and fall out of the seating.The fall resulted in an injury requiring medical intervention to address.

• Brand Name: PERMOBIL M3
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 19939334
• Report Number: 1221084-2024-00015
• Device Sequence Number: 7340247
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: M3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Prefer Not To Disclose