MAUDE Adverse Event Report: MAX MOBILITY LLC SMARTDRIVE

Model Number MX2+

Device Problems Self-Activation or Keying (1557); Activation, Positioning or Separation Problem (2906); Activation Problem (4042)

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

Received report claiming while dealer was setting up a smartdrive device, when testing the switch control buttons, one side turned on and the smartdrive immediately engaged the drive motor and would not disengage unless the smartdrive unit was powered off.No injury as a result.

Manufacturer Narrative

The switch control button assembly was returned to permobil for inspection/evaluation.Further analysis of component, and operational testing of switch control buttons confirmed the report of involuntary activation of drive motor without the need to depress the button, and the failure to disengage motor once depressed.Due to the report and confirmation of a component malfunction, a capa investigation was initiated.A review of the hazard risk analysis was conducted, and this failure mode was found to remain low, however permobil will continue to monitor any further reports through trend analysis and take appropriate actions.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 15527905
• MDR Text Key: 305359635
• Report Number: 3008370857-2022-00006
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• 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?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• 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