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.
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