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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

Received report of having received new smartdrive unit and when connecting the switch control buttons, the unit would not operate.Provider stated they were able to finally get it to operate but would engage and disengage drive with the slightest touch.No injury occurred because of this reported issue.

Manufacturer Narrative

Investigation confirmed reported failure mode of intermittent involuntary activation of smartdrive device via suspect switch control.Evaluation of suspect component is under investigation as part of the capa process.Capa investigation 22- 013 is in progress.Permobil will continue to monitor this failure mode through trend analysis.The dhr was reviewed, and this 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: 15362907
• MDR Text Key: 302875307
• Report Number: 3008370857-2022-00003
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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: Prefer Not To Disclose