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	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The end-user had downloaded the most updated version of mx2+ app, but when having difficulty installing, contacted permobil australia for assistance.It was at this point the end-user claimed the samsung galaxy 5 watch failed to disengage the drive motor of the smartdrive device when given tapping gestures.The end-user stated he was able to stop by pressing the button on the watch, but tapping did not register.Permobil australia was able to wlak the end-user through the installation, but they were unable to confirm which version of app was previously installed on the watch prior to the user updating.Since the update, no further communication has been received from the user of recurring issues.Permobil is unable to reach a determination as to possible cause for the alleged issue without speculation.
Event or Problem Description
Received report claiming the end-user having connection issue with the galaxy 5 watch causing a loss of control with the smartdrive unit where they did not have the ability to stop via tapping gestures.No injuries were reported to have been received 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: 24462428
• Report Number: 3008370857-2026-00327
• Device Sequence Number: 15803493
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)240716
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/26/2026

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: 02/10/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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