SMARTDRIVE
Report
- Report Number
- 3008370857-2026-00339
- Event Type
- Malfunction
- Date Received
- May 20, 2026
- Date of Event
- April 5, 2026
- Report Date
- May 20, 2026
- Manufacturer
- MAX MOBILITY LLC
- Product Code
- ITI
- UDI-DI
- 00861896000310
- PMA / PMN Number
- K151199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560320 | SMARTDRIVE | SMARTDRIVE | ITI | MAX MOBILITY LLC | MX2+ | 00861896000310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |