MAUDE Adverse Event Report: MAX MOBILITY LLC SMARTDRIVE

Model Number MX2+

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Head Injury (1879); Skin Tears (2516)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

The client was operating the smartdrive with his chair up a ramp at a local gas station.The client stated that they attempted to shut down the smartdrive once at the top of the ramp, but the unit continued to propel the client.The secondary action was the client, chair and the drive unit propelled off a curb.The client sustained an injury that required stitches.Max mobility requested the device to be returned for evaluation in order to determine any potential device malfunctions or failure.Max mobility received the device on 01/06/2021 (serial number: (b)(4)) for evaluation.The evaluation is on-going.It can be noted that the device employs redundant designs for deactivation, so that if one means were to fail (which can be considered to be "improbable") regardless of reason (i.E.User not sufficiently performing the action necessary) there is always a second means (i.E.Turning power assist off).There are no past complaint records for the particular device.Max mobility shall conduct a detailed investigation of this event in accordance to its complaint handling procedures.As applicable, a follow-up report will be completed and submitted accordingly.

Event Description

The client was operating the smartdrive with his chair up a ramp at a local gas station.The client stated that they attempted to shut down the device once at the top of the ramp, but the unit continued to propel the client.The secondary action was the client chair and smartdrive unit propelled off a curb.The client sustained an injury that required stitches.

Manufacturer Narrative

On (b)(6) 2020, max mobility received the specific device (smartdrive/drive unit serial number (b)(6) with pushtracker e2 serial number (b)(6)) and had the unit quarantined to prevent any tampering prior to investigation.The device was set to operate in mx2+ control mode with 70% max speed limit, 30% acceleration rate and 70% tap sensitivity as the device settings.After extensive in-house evaluation/testing (approximately 2.5 hours) of the specific unit was performed by engineering on (b)(6) 2021 in many situations (i.E.Outdoors, on multiple surfaces, on inclines/declines, bumpy/sidewalk cracks, power-assist/sd on and sd off, etc.), the device showed absolutely no signs of defects and operated without any issues or malfunctions.For this type of failure or occurrence (failure to follow instructions, user / operator error from continued operation after attempted deactivation caused or contributed to event), the device design and the control measures to prevent this type of occurrence were also reviewed for their acceptability.These control measures include instructions for use (caution for intended conditions for use and recommended actions/operation for certain environments, instruction for when to turn power assist off, deactivation/activation instruction), activation and deactivation criteria, "tap" sensitivity, switch control use, among others.In the initial report, it was noted that the device employs redundant designs for deactivation, so that if one means were to fail (which can be considered to be "improbable") regardless of reason (i.E.User not sufficiently performing the action necessary) there is always a second means (i.E.Turning power assist off).In conclusion, no device malfunction was identified, no corrective action is needed at this time.Complaints are monitored for similar trends in accordance to the quality system procedures.

• Brand Name: SMARTDRIVE
• Type of Device: SMARTDRIVE
• Manufacturer (Section D): MAX MOBILITY LLC; 300 duke drive; lebanon TN 37090
• MDR Report Key: 11148093
• MDR Text Key: 226100663
• Report Number: 3008370857-2021-00001
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00861896000303
• UDI-Public: 00861896000303
• Combination Product (y/n): N
• PMA/PMN Number: K151199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other