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	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The end-user reports using an apple watch as the primary controller and over time has been having connectivity issues, primarily where the smartdrive device will no longer pair wirelessly and when it does, will lose connection.Claims the current issue with the smartdrive device now is when they turn it on via the power switch, claims the motor will immediately engage a drive command.The end-user stated he did not have the wearable paired when this occurred and the mx2+ app was not in focus.The end-user stated there arent any other control methods being connected to the device.Permobil discussed the age of the device having exceeded useful life expectancy, and the potential for component failure within.The end-user stated that he has discussed service with their provider and they chose to replace the device with new as opposed to repair.Although permobil was able to confirm a product malfunction having occurred, due to the age of the product, and being unavailable for evaluation, permobil is unable to reach a determination as to posible root cause without speculation.If any new information is received, a follow-up report will be submitted.
Event or Problem Description
The end-user reports when powering on the smartdrive device, claims the device will immediately engage the motor without any physical commands being given from the wearable controller.No injuries were 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: 25578512
• Report Number: 3008370857-2026-00344
• Device Sequence Number: 9020607
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)180529
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/22/2026

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: 06/08/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2018
• 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