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	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report claimed after having engaged a drive command via switch controls w/buddy button, when pressing the switch a second time to disengage the smartdrive motor, on occasion the device continued to run.Permobil representative inspected the device and controller, and reported they were able to replicate the reported failure.Further inspection shown signs of the cabling for the switch control and buddy button being secured with zip ties in such a manner that the ties were pinching and possibly damaging the cable to where it would potentially interrupt the signal when the button was pressed.Suspect components were replaced with new and operationally tested with no further issues of recurrence.At this time, permobil has yet to receive suspect component for evaluation to confirm the reported failure mode.If any new information is received, a follow-up report will be submitted.
Event or Problem Description
Received report claiming inconsistent performance with the switch control with buddy button option, claiming once activated the smart drive would not shut off with a second press of the switch.
Additional Manufacturer Narrative
Evaluation of returned components was conducted where through inspection, it was found the cables to the switch control w/mono jack and buddy button had sustained internal damages that when the cable harness was manipulated, it would lose connection and render the switch inoperable.The damages are being related to improper installation in that the excess cabling was overtightened via zip-ties and damaged the internal wires causing them to lose connection.The remaining switch control button was not affected and remained fully functional.It is permobil contention this reported failure was the result of physical damages to the cables of the switch control w/mono jack and buddy button that occurred after initial 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: 24387976
• Report Number: 3008370857-2026-00323
• Device Sequence Number: 13331943
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)250515
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: 01/23/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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