MAUDE Adverse Event Report: MAX MOBILITY LLC SMARTDRIVE

Model Number	MX2+
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a routine communication with permobil, the end-user made mention of an incident that had occurred approximately 2 years prior where the reported having been injured while using the smartdrive mx2+ device.Reports while under power with the device, the manual wheelchair hit a dip or crack in the sidewalk which caused the wheelchair to become blocked from forward momentum.Report indicated it occurred so quickly that the end-user did not have time to power the smartdrive device off via the controller, and the device continued to run which lifted the wheelchair up, reportedly causing the end-user to lose positioning and fall to the ground where they sustained a fracture to their right tibia and fibula requiring surgery to address.The end-user did not make any claim or allegation of a device malfunction having occurred to have caused this event, only that it had occurred and the device remains operational but were no longer using the device.A review of the device history record from the date the device was manufactured was performed which noted that this device was not involved in manufacturing quality non-conformance.The device met all quality criteria prior to its release.
Event or Problem Description
Reports while driving down a sidewalk while under power with the smartdrive device, at one point the manual wheelchair hit dip in the sidewalk causing the wheelchair to stop forward momentum.Reports indicate when this occurred, the smartdrive device continued to drive forward and roll underneath the wheelchair which caused the end-user to lose positioning and fall to the ground where they received a serious injury.

• Brand Name: SMARTDRIVE
• Common Device Name: SMARTDRIVE
• Manufacturer (Section D): MAX MOBILITY LLC; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): MAX MOBILITY LLC; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 24900537
• Report Number: 3008370857-2026-00332
• Device Sequence Number: 18312109
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)211207
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151199
• 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): 04/16/2026

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: MX2+
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown