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	Limb Pain (4836)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
End-user claims while using their manual wheelchair, equipped with a smartdrive and switch controls with mono jack and buddy button, when attempting to disengage the drive motor by pressing the buddy button, claims the motor failed to disengage forcing the end-user to maneuver the wheelchair into a tree.No serious injuries were received as a result.
Additional Manufacturer Narrative
Suspect device and controls were examined and were found to remain fully operational with no signs of a malfunction having occurred.Testing was conducted in the field with the primary device and controller with the controller properly starting and stopping the smartdrive device as per design.Permobil was unable to replicate any failure as alleged as having occurred.Suspect controller is still in use with no further reports of recurring behavior.Permobil is unable to reach a determination as to possible root cause without speculation.A review of the device history record from the date the device was manufactured was performed which noted that this dev ice was not involved in manufacturing quality non-conformance.The device met all quality criteria prior to its release.

• 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: 24747527
• Report Number: 3008370857-2026-00331
• Device Sequence Number: 13052883
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)240319
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/31/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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