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	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
End-user claims while using their manual wheelchair, equipped with a smartdrive and speed control dial, the smartdrive unit reportedly accelerated without notice causing the end-user to lose control of the wheelchair where it flipped on to its side.This reportedly resulted in an injury to the end-user.
Additional Manufacturer Narrative
Due to an increase in reports of similar failures, a capa investigation was implemented.Investigation found an undesirable interaction between the circuit design and the new potentiometer over time.Further engineering analysis concluded that the new potentiometer's internal contact resistance was changing during use, and the circuit was overly sensitive to this change.The investigation also showed that the internal contact resistance of the previous potentiometers, used prior to (b)(6) 2023, did not change much over time when compared to the new potentiometer, concluding the root-cause for the failure was within the new potentiometer.As part of corrective actions, max mobility has initiated a field action recall for all speed control dials that are currently in use.Max mobility will be providing switch control buttons or switch control buttons with mono jack option to replace the affected speed control dials.

• 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: 24616779
• Report Number: 3008370857-2026-00330
• Device Sequence Number: 10333868
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)240215
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2538-2025 THROUGH Z-25
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown