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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report claimed after pressing the switch control button to disengage the drive motor of the smartdrive, the unit reportedly continued to drive where the end-user impacted a table.No injuries were reported to have been sustained as a result.Permobil has issued an rma to have the smartdrive device, and all controllers returned for evaluation in effort to identify a possible cause for the reported event.At this time, permobil has yet to receive the suspect device or controllers, therefore is unable to reach a determination as to possible root cause at this time.If any new information is received, a follow-up report will be submitted.
Event or Problem Description
Reports while sitting at a table in a restaurant, the smartdrive unit reportedly engaged a drive command without physical manipulation of the controller and claims being unable to stop the motor by pressing the switch control button, requiring a friend to turn the smartdrive off.No injuries occurred as a result.

• 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: 24953012
• Report Number: 3008370857-2026-00335
• Device Sequence Number: 5265521
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)240521
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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