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 Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 09/26/2022

Event Type  Injury  

Event Description

Report claims as end-user attempted to disengage the drive motor on their smartdrive unit via a double tap of the smart watch, the device reportedly continued to drive causing the end-user to impact a bystander with their wheelchair resulting in an injury to the bystander.

Manufacturer Narrative

The end-user has had the smart drive for approximately a year and claims having had a few incidents where they were unable to get the smart drive to stop.Permobil representative reports having inspected the smartdrive device with smart watch and was found to be functioning normal.Device remained set to factory settings with no findings out of the ordinary.Representative reports being unable to replicate failure to stop as reported by the customer.Per additional conversation with the end-user's therapist, they indicated there may be some confusion, by the end-user, on how to operate the smart watch in an emergent situation.It was also mentioned the end-user was unsure of how to change the settings on the watch.The end-user was provided a rotary dial (wired) option as an alternative to the smart watch (bluetooth).End-user reports having better control with the alternative control.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: 15707337
• MDR Text Key: 302766799
• Report Number: 3008370857-2022-00008
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• 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: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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 Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose