MAUDE Adverse Event Report: MAX MOBILITY, LLC SMARTDRIVE

Model Number MX2+

Device Problems Detachment Of Device Component (1104); Installation-Related Problem (2965)

Patient Problem Joint Dislocation (2374)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Inspection of the manufacturing records showed the specific device and all its parts were manufactured to specification, passed all quality checks, and were released after final testing of the device was performed.The specific device was manufactured / released on 1/30/2018.There are no past service / complaint records for the particular device and it had not been returned or brought in for service at any time in the past.So the date of 3/21/2018 as the first of max mobility became aware holds true and the handling of everything according to the established quality system procedures was verified.The sales representative / event reporter, accompanied by a technician from the user's durable medical equipment provider (dme) responsible for initial set-up / mounting of the smartdrive attachment hardware to the wheelchair, met with the user on (b)(6) 2018.Verification was first completed to make sure correct hardware was employed for the specific wheelchair.Next, upon examination of the attachment hardware it was discovered that it was not oriented level and instead rotated downward.Consequently the sales representative, with observation of the dme technician, proceeded to make an adjustment to the attachment hardware on the wheelchair, using the bubble-level tool provided with all new attachment hardware of its type to make sure it was sufficiently level and mounted according to the labeling / instructions.The user then demonstrated complete and appropriate use of the device, to include attaching the smartdrive to the now adjusted attachment hardware.The user commented that the smartdrive felt more stable and less "wobbly" after the adjustment, and indicated that it "always felt wobbly" from the time she first began using the device.From this information it was concluded by engineering / quality system manager that the attachment hardware was not installed / initially set-up as intended or instructed in the device labeling and using the tools provided with it to assist with verification.This was concluded as the user indicated that the smartdrive "always felt wobbly." this indicates the attachment hardware was not oriented correctly to allow for intended, full smartdrive engagement with the attachment hardware.Consequences of incomplete engagement of the smartdrive to the attachment hardware include the ability of the device to have a perceived "wobble" while riding on or driving the wheelchair.Another significantly less likely consequence, which was the case in this occurrence, would be that under certain dynamic situations / environmental conditions experienced the smartdrive can disengage from the attachment hardware and come off the wheelchair.When the attachment hardware is set-up / mounted correctly, as instructed in the "axle clamp mounting instructions" along with using the tools provided with each device / attachment hardware, the smartdrive is not able to "wobble" nor become disconnected from the attachment hardware and consequently come off the wheelchair under even the most extreme use conditions.Engineering noted that the smartdrive device itself, whether attached correctly, or the act of coming off and then being completely removed from the wheelchair, does not provide or cause turning of the wheelchair.It is recognized that the smartdrive coming off the wheelchair could have contributed to the user being distracted from safely operating / steering the wheelchair.But the cause of the user to veer into the embankment can only be contributed to the user, the wheelchair, the environment or any combination, all of which the user is responsible for selecting, controlling and navigating safely whether a smartdrive is attached / present / in-use or not.There were no indications from the user or sales representative that the wheelchair was veering unexpectedly or unintendedly prior to or after the occurrence, so it can only be assumed that the user, environment or a combination was responsible for the veering.For this type of event (failure to follow instructions, use error caused or contributed to event) for this and all models / attachment hardware, the device design and the control measures to prevent this type of occurrence were also reviewed for their acceptability - which was verified.These control measures include sufficient labeling / instructions for use (ifu) and the providing of tools with the device to aid with correct installation / set-up and verification of such, among others.In conclusion, no immediate corrective action is needed, as the device is designed to reduce the amount of risk of this type as far as possible, the design is safe, the unit was manufactured to specification, sufficient instruction is given, and it functioned as expected.This occurrence, complaint and investigation will be again reviewed for additional occurrences / trends as part of other quality system procedures which might warrant future corrective action and / or updating of risk management activities.

Event Description

As described to the quality system manager by sales representative, user was operating smartdrive model mx2+ and, after failing to recognize the attachment hardware was not installed / initially set-up as intended and instructed in the device labeling, allegedly had the smartdrive / drive unit come off of the wheelchair.Upon the smartdrive / drive unit no longer being attached to the wheelchair, the user then veered into an embankment.As a cause of impacting the embankment the user sustained a dislocated knee (which "went right back in") and neck soft tissue injury ("whiplash type"); no damage was reported to be done to the wheelchair.

• Brand Name: SMARTDRIVE
• Type of Device: SMARTDRIVE
• Manufacturer (Section D): MAX MOBILITY, LLC; 5425 crossings blvd.; antioch TN 37013
• Manufacturer (Section G): MAX MOBILITY, LLC; 5425 crossings blvd.; antioch TN 37013
• Manufacturer Contact: ben hemkens ; 5425 crossings blvd.; antioch, TN 37013 ; 8006372980
• MDR Report Key: 7449278
• MDR Text Key: 106139008
• Report Number: 3008370857-2018-00002
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00861896000303
• UDI-Public: 00861896000303
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K151199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MX2+
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR