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	04/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Permobil australia received a report indicating the end-user was in a store and had stopped the smartdrive device using the switch control button w/mono jack, then suddenly the smartdrive reportedly engaged a drive command without any physical manipulation of the switch and was reportedly unable to stop when pressing the switch.This forced the end-user to pull the switch control by the plug end in order to stop.No injuries were reported to have been sustained as a result of the event.Service provider reported to permobil that they were initially unable to replicate a failure, then later reported to have replaced the cable under warranty.Permobil australia has requested the suspect component be returned for evaluation, and at this time permobil has not received any product to evaluate and is unable to reach a determination as to possible root cause without speculation.If any new information is received, a follow-up report will be submitted.
Event or Problem Description
Report of switch control w/mono jack and buddy button having been pressed to stop, then unexpectedly engaged the smartdrive motor to where the end-user reportedly could not stop with a press of the controller buttons.No injury was reported to have occurred 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: 25233950
• Report Number: 3008370857-2026-00339
• Device Sequence Number: 21421902
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)231219
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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