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	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Permobil ab received a report that claims the end-user's partner touched the jack of the buddy button, and this reportedly caused the smartdrive to engage a drive command.Claims having pressed the buddy button to disengage the drive motor but did not stop the smartdrive.Reports indicate the service provider was unable to replicate the alleged malfunction during inspection.Permobil ab has requested the suspect component be returned for evaluation, and at this time permobil has not received any product 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
Received report claiming while using the smartdrive with a switch control w/mono jack and a buddy button, their partner reportedly touched the connection plug where the buddy button plugs in and this reportedly caused the smartdrive device to engage a drive command.Reports claim it caught the end-user off guard where they lost positioning and fell from the wheelchair.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: 25174567
• Report Number: 3008370857-2026-00338
• Device Sequence Number: 13392816
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)221214
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/14/2026

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: 04/24/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2022
• 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