During the validation of a pending design change to provide the smartdrive mx2+ application for android wearables, engineering identified a missing code in the application related to anr (application not responding) where if the application crashes due to an anr, the error handling logic fails to stop the bluetooth communication to the smartdrive mx2+ drive unit.As a result, the motor continues to run, and the user may not be able to disengage the device using tap gestures.A capa, (b)(4) was opened to investigate this failure, and as part of that investigation, a search of client files was conducted for any reports of "failure to disengage".Although permobil was unable to confirm that the root-cause associated with these reports was an anr error, information outlined in the capa investigation suggests that the allegations related to failure to disengage drive by tap gestures could be because of an anr error which if to reoccur, has the potential to lead to a serious injury.The dhr was reviewed, and the device was found to have met specification prior to distribution.
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Received report claiming as end-user was exiting their classroom, they tapped the smart watch to engage drive where it was alleged the device started at full speed.Claims device was unresponsive when given a double tap gesture of the smart watch, forcing the end-user to pin themselves against a vending machine to stop drive.No injuries occurred as a result of this event.
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