Inspection indicates a weldment point on the recline actuator mounting bracket having broken away.This weldment is where the recline actuator is secured, and in whole, is attached to the seat frame.It was reported when this component broke, it allowed the back hinge to no longer remain upright as the recline actuator was no longer secured.Reports indicate when the failure occurred, the end-user was in process of performing a recline function when the backrest had given way and fell flat.End-user reported this caused them to fall back, and out of the seating where they struck their head on the ground.As a precautionary measure, the end-user was taken to the local hospital where a ct scan was performed.End-user reported that the test results were negative of having sustained any serious injury with the end result being that of a slight bump on the head.This is a known failure mode and following an investigation, permobil concluded no unusual or significant deterioration of the components were detected.To assess the full impact of this failure mode, capa (b)(4) has been opened to further investigate, correct and monitor effectiveness.The recline actuator and suspect bracket met acceptable performance margins and replacement components were approved for distribution.The service provider was supplied parts quote for the approved parts in order the repair of the device and return to the end-user.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.
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