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 Codes	Abrasion (1689); Bruise/Contusion (1754)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report claimed when the end-user pressed the switch control to stop the mx2+ smartdrive unit, the device failed to disengage the drive motor and continue to drive.This reportedly caused the end-user to lose control of their manual wheelchair which resulted with them losing positioning and falling out of seating where they sustained some bruising to the thigh and abrasions to their upper appendages.The end-user reported they pressed the button multiple times and received no response.At this time, permobil ab has yet to receive the suspect switch control for inspection, thus is unable to reach a determination as to possible root cause for the alleged failure to disengage drive.If any new information is received, a follow-up report will be submitted.Review of the dhr indicates the device met specification prior to distribution.
Event or Problem Description
Permobil ab received report claiming as the end-user was under power with a smartdrive device using switch controls.It was reported when pressing the switch control to disengage the drive motor, the device reportedly failed to stop.This reportedly caused the end-user to fall out of their manual wheelchair resulting in minor injuries.No medical intervention was sought.

• 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: 24548097
• Report Number: 3008370857-2026-00329
• Device Sequence Number: 9404481
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)250729
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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