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	Abrasion (1689)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reports having ongoing issues with the smartdrive claiming the wireless control methods used on the device were not working correctly to where they would engage a drive command by themselves or lose drive without command.Claims on one occasion the device wouldn't stop when given a tapping motion and they tried to stop by putting feet on ground where they injured their toe.No medical intervention was sought.
Additional Manufacturer Narrative
Suspect smartdrive and manual wheelchair had been purchased by the end-user via an online retailer.The end-user assembled and installed the smartdrive device onto the wheelchair and did not receive any formal training on the operation of the device.Reports having installed the mx2+ app on to their personal apple watch, and the end-user reported on occasion the drive would either not engage or disengage without being given a command via tapping of the watch.On one occasion reports the device failed to stop after given a tapping command and this forced the end-user to drop their feet to the ground in an attempt to stop the mwc.This reportedly led to the end-user receiving an abrasion to their toes that was remedied by otc medications and bandages.The end-user decided the purchase did not meet their needs and returned the product.Permobil conducted testing on the smartdrive and was unable to reproduce any failures as alleged.The device was found to remain fully operational with no signs of a malfunction having occurred.Permobil is unable to reach a determination as to probable root cause for this report without speculation.Th dhr was reviewed, and the device was found to have met specification prior to distribution.

• 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: 25348133
• Report Number: 3008370857-2026-00341
• Device Sequence Number: 10748404
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)251229
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2025
• 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