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	Discomfort (2330)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reports while driving their manual wheelchair while under power with a smartdrive device with switch control buttons.Reports when pressing the switch control to stop, claims the device started to slow down but then sped up and continued under power.This reportedly caused the end-user to panic and turn the wheelchair where they impacted a wall.No serious injuries were received as a result of this event.
Additional Manufacturer Narrative
Report claimed after pressing the switch control button to disengage the drive motor of the smartdrive, the unit started to slow but then increased speed and continued to drive.The end-user reported having panicked and steered the wheelchair into a wall.Report claims after impacting the wall they pressed the button again and the drive motor stopped.The end-user stated they were not seriously injured as a result but suffered some general soreness to the right side of their body.The end-user stated this event was the only time the switch did not disengage drive, and they are currently using the switches with no cases of recurrence.With the information provided, permobil was unable to confirm a product failure having occurred, and without any return product to evaluate, 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 device 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: 24932295
• Report Number: 3008370857-2026-00333
• Device Sequence Number: 10727366
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)230913
• 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): 04/20/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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