MAUDE Adverse Event Report: MAX MOBILITY LLC SMARTDRIVE

Model Number MX2+

Device Problems Electrical /Electronic Property Problem (1198); Device Remains Activated (1525); Failure to Shut Off (2939)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

During the validation of a pending design change to provide the smartdrive mx2+ application for android wearables, engineering identified a missing code in the application related to anr (application not responding) where if the application crashes due to an anr, the error handling logic fails to stop the bluetooth communication to the smartdrive mx2+ drive unit.As a result, the motor continues to run, and the user may not be able to disengage the device using tap gestures.A capa investigation, 23-002, was opened to address this issue.As part of the investigation, it was determined the way to identify if an anr event occurred could be detected by the screen on the wearable.If it is reported the screen is blank/dark during or just after the event, or if the end-user recalls the need to restart the mx2+ application to restore operation, these actions will indicate a possible anr crash having occurred.The end-user stated when attempting to stop the sd device with the e2 watch via a tapping motion, claims the device continued to run, forcing them to maneuver into a wall to stop.Claims this has occurred numerous times since they have had the smartdrive device (2021) with e2 tic watch.The end-user stated they did not have any knowledge of the market correction and had not performed an update to the mx2+ app.The end-user stated they do not believe the app ever crashed as they recall turning the app off after the event occurrences.The end-user stated they are no longer using the e2 tic watch and has resorted to using a wired controller (speed control dial).As the end-user reported not having any recollection of the app crashing, and although not currently using the e2 tic watch, it was remaining operational after the events, permobil is unable to reach a determination as to probable root cause without speculation.The dhr was reviewed, and the device was found to have met specifications prior to distribution.

Event Description

The end-user reports while under power of the smartdrive mx2+ device, when they attempted to disengae the drive via a tapping motion of the e2 tic watch, the device reportedly continued to drive.This action forced the end-user to maneuver the wheelchair into a wall in order to stop.No injuries were rpeorted to have occurred as a result.

• Brand Name: SMARTDRIVE
• Type of Device: SMARTDRIVE
• Manufacturer (Section D): MAX MOBILITY LLC; 300 duke dr; lebanon TN 37090
• Manufacturer (Section G): MAX MOBILIT LLC; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 18727074
• MDR Text Key: 336435289
• Report Number: 3008370857-2024-00006
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MX2+
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose