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	Concussion (2192)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report indicates a failure having occurred where the smart drive device reportedly initiated a drive command without physical manipulation of the apple watch, and failure to disengage a drive command when given tapping gestures.Report claims the end-user attempted to disengage a drive command via tapping gestures with the apple watch, but the device reportedly continued to drive.This reportedly forced the end-user to maneuver the wheelchair into a wall where they lost positioning and fell to the floor.It was reported the ensuing fall resulted in the end-user striking their head resulting in a concussion.The end-user reported they have 2 different apple watches, and this anomaly of failure to disengage has occurred sporadically with both watches.Permobil has requested the smartdrive device be returned for evaluation with request for one or both of the wearables be returned for testing with unit.It was agreed to return the smartdrive mx2+, but as the apple watches are the user's property, they will not be returning.At this time, permobil has yet to receive the suspect device for evaluation.If any new information is received, a follow-up report will be submitted.
Event or Problem Description
Reports having instances while using the smartdrive device under power, where when tapping the apple watch to disengage the drive motor, the unit continued to drive.This reportedly forced the end-user to impact a wall where they lost positioning and fell to the ground requiring medical intervention.
Additional Manufacturer Narrative
Visual inspection noted the lower housing having been broken to where the internal components were exposed.Unit was found to be covered in what appears to be dried salt residue.Inspection of the charge port shown signs of considerable corrosion to where one of the 6 data pins was no longer viable for use.Unit was able to power up normally and was connected with test wireless controller (wearable).Operational testing with wearable had the device engage and disengage drive normally with no hesitation.Attempts to use wireless controls were unsatisfactory due to corrosion build up within the charge port.It was noted there was some excessive motor noise during operation.Permobil was unable to reach a determination for the motor noise without speculation.Through testing, permobil was unable to replicate the reported "inability to stop" with a wearable item.It should be noted the device was not returned with either of the apple watches the end-user claimed to have been used during the reported events.Permobil replaced all components that were affected by external damages, operationally tested the device satisfactory and returned to provider.

• 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: 24344770
• Report Number: 3008370857-2026-00321
• Device Sequence Number: 9836227
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)221001
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 01/27/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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