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 Abrasion (1689); Bruise/Contusion (1754)

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

The client stated that they attempted to shut down the smartdrive unit by performing a tapping motion, but the unit continued to propel the wheelchair reportedly forcing the end-user to collide into a table.Claims the only way to stop the device was to tun off power at the source.Permobil requested the device to be returned for evaluation to determine any potential device malfunctions or failure.Permobil received the device on (b)(6) 2022, and had the unit quarantined to prevent any tampering prior to evaluation conducted on (b)(6) 2022.Evaluation shown mx2+ unit was fully charged, but e2 pt had < 10% charge not allowing it to connect via bt with drive unit.Once sufficiently charged, testing of device was conducted.The device was set to operate in mx2+ control mode with 60% max speed limit, 30% acceleration rate and 65% tap sensitivity as the device settings.Testing shown e2 pairing with mx2+ properly and unit was operationally tested for approximately 1.25 hours with no failure occurring.Throughout testing, the device started and stopped by incorporating the "double tap" of the e2.Also testing of the redundant controls of screen tap and button press of the e2 also disengaged drive.Testing of switch drive was conducted and depress of physical switch also disengaged drive as per design.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.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, there are no past complaint records for this specific device, no device malfunction was identified, therefore no corrective action is needed at this time.Complaints are monitored for similar trends in accordance with the quality system procedures.The dhr was reviewed, and the device was found to have met specification prior to distribution.

Event Description

Received report where end-user claims having attempted to disengage the smartdrive power unit by giving a tapping motion, but unit would not respond to their command and continued to run forcing the end-user to collide into a table.No serious injuries occurred because of this event.

• 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: 13591829
• MDR Text Key: 286065588
• Report Number: 3008370857-2022-00001
• 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
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• 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 Sex: Male