MAUDE Adverse Event Report: MAX MOBILITY LLC SMARTDRIVE

Model Number	MX2+
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Remains Activated (1525); Failure to Shut Off (2939)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report indicates a failure having occurred where the smart drive device reportedly initiated a drive command without physical manipulation of the switch controls.Report claims the end-user attempted to disengage a drive command via the switch control buttons and the device reportedly continued to drive.This reportedly forced the end-user to maneuver the wheelchair into an immoveable object where they sustained minor bruising injuries to their legs.The end-user reports they have one switch mounted in the front of the wheelchair for their access, and the second switch mounted to the push handle area for an attendant.The end-user was provided a replacement set of switch controls, with the suspect controller being returned to permobil for evaluation.At this time, permobil has yet to receive the suspect component, thus is unable to reach a determination as to possible cause for the alleged malfunction.If any new information is received, a follow-up report will be submitted.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.
Event or Problem Description
Reports while in a grocery store, the smartdrive unit engaged a drive command without any physical manipulation of the switch control button, reportedly causing the end-user to impact an immoveable object with the wheelchair.No serious injuries were reported to have occurred as a result of this event.
Additional Manufacturer Narrative
Permobil received suspect controller for inspection and evaluation.Through testing, permobil was unable to replicate any failure of involuntary activation as alleged, nor noted any signs of a product malfunction having occurred with the switch controller, finding it to remain fully operational as per design.Permobil is unable to reach a determination as to possible root cause of the alleged malfunction without speculation.

• 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: 24332627
• Report Number: 3008370857-2026-00320
• Device Sequence Number: 18589558
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)250213
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MX2+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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
• Patient Sex: Unknown