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	07/20/2026
Type of Reportable Event	Malfunction

• 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 ; +1(800)736-0925
• MDR Report Key: 50224543
• Report Number: 3008370857-2026-00354
• Device Sequence Number: 5432711
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)250403
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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+
• Device Catalogue Number: n/a
• Device Lot Number: n/a
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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