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 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

During the validation of a pending design change to provide the smartdrive mx2+ application for android wearable's, 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, 23-002 was opened to investigate this failure, and as part of that investigation, a search of client files was conducted for any reports of "failure to disengage".Although permobil was unable to confirm that the root-cause associated with these reports was an anr error, information outlined in the capa investigation suggests that the allegations related to failure to disengage drive by tap gestures could be because of an anr error which if to reoccur, has the potential to lead to a serious injury.The dhr was reviewed, and the device was found to have met specification prior to distribution.

Event Description

Received report claiming smart drive device failed to stop when given a double tap gesture with teh smart watch.No injuries occurred as a result of this event.

• Brand Name: SMARTDRIVE
• Type of Device: 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: 16814337
• MDR Text Key: 313993672
• Report Number: 3008370857-2023-00008
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: 00861896000310
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• 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: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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