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	Bruise/Contusion (1754)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report claims the smartdrive device engaged a drive command without any physical manipulation of the switch controls.Permobil has requested the switch controls be returned to permobil ab for evaluation in effort to determine a probable cause for the alleged malfunction.The end-user is being provided a replacement set of switch controls, but suspect controls have yet to be received at permobil ab as of this report date.If any new information is received, a follow-up report will be submitted.
Event or Problem Description
Reports while sitting in a classroom at school, the smartdrive device reportedly engaged a drive command without any physical manipulation of the switch control buttons.This reportedly forced the wheelchair into a desk where the end-user sustained some bruising to their chest.No medical intervention was sought 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: 24462427
• Report Number: 3008370857-2026-00326
• Device Sequence Number: 9403673
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)220517
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K151199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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