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

Model Number	M3
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reports leg rest assembly was unable to retract fully and this caused the end-user to run their leg into the van door when attempting to enter vehicle.Report indicates the end-user sustained injuries requiring medical intervention to adress.
Additional Manufacturer Narrative
Report indicated after the service provider had replaced the leg rest assembly in early february, the leg rest never fully returned to a 90° angle, and the end-user continued to use the device in that state.Reports in mid-february, the end-user was attempting to enter a transport vehicle, and with the leg rest being partially elevated (approx 30°), the end-user's leg reportedly caught the door frame of the van resulting in a fx to their right tibia.Inspection of device confirmed leg rest being unable to fully retract, and determined the cause as being an improper component having been installed on the device that was mechanically binding, not allowing the leg assembly to fully retract.Review of device history indicates per mobil having provided an incorrect component, and was subsequently installed by the dealer.Correct component has been provided to dealer, installed on device, and operationally tested satisfactory.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• 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: 18983470
• Report Number: 1221084-2024-00007
• Device Sequence Number: 15506183
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

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?: No
• 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: Not provided
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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