MAUDE Adverse Event Report: MAX MOBILITY LLC SMARTDRIVE

Model Number MX2+

Device Problems Unintended Power Up (1162); Electrical /Electronic Property Problem (1198); Power Problem (3010)

Patient Problem Joint Dislocation (2374)

Event Date 04/16/2022

Event Type  Injury  

Manufacturer Narrative

End-user reports as they were crossing a street in their manual wheelchair, the attached smartdrive power assist unit powered on to engage a drive, without command, propelling the wheelchair w/end-user at speed.Claims made that end-user attempted to disable drive by pressing the attached switches, but the command did not stop the unit.Reports indicate the device continued to propel until the wheelchair impacted a retaining wall.The impact caused the end-user to lose positioning and fall to the ground.End-user reports having dislocated their shoulder but repositioned it themselves.End-user stated they did not seek medical intervention as they are susceptible to dislocation and are accustomed to resolve on their own.The end-user reports having replaced the switch set approximately 2 weeks prior to the event and have been having intermittent issues since installation.Out of an abundance of caution, permobil has replaced the smartdrive unit and switch set with new and is planning for the suspect components be returned to permobil for inspection/evaluation in effort to determine a possible root cause.At this time permobil has not received the suspect components therefore a determination cannot be made.When new information is received, permobil will submit a follow-up report with their findings.The dhr was reviewed and the device was found to have met specification prior to distribution.

Event Description

End-user reported while crossing street in their manual wheelchair, equipped with a smartdrive power assist unit, the smartdrive unit was reported to have engaged drive, without command, and accelerated at full speed.Reports claim the unit would not stop when given command via switches and the wheelchair continued to drive causing the wheelchair to impact into a retaining wall.This resulted in the end-user falling out of the wheelchair seating resulting in an injury to the end-user.

Manufacturer Narrative

Due to the report of an injury having occurred because of a confirmed component failure, 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.Further analysis of components, switch control button assembly and smartdrive unit, were returned to permobil for inspection/evaluation was conducted.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.

• 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; lebaon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 14435925
• MDR Text Key: 292026953
• Report Number: 3008370857-2022-00002
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• 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 Outcome(s): Other
• Patient Sex: Female