In the course of investigation the arjo representative mentioned also that the customer communicated an additional issue with the mattress involved in this event.It allegedly resulted in creating a bulge in the middle of the mattress.The arjo representative together with the arjo technician visited the customer to inspect the device.The technician released some air from the mattress cells valve to solve the complained symptom.This mattress is a reactive mattress equipped with sat (self-adjusting technology) system with 9 hybrid cells (inflatable, filled with foam) located across.The pressure in the cells adjusts depending on the applied load.It means that the air is moving from one cell to another depending on where the load is placed.The complaint indicated that the patient fell to one site of the mattress, however if the air in one cell would have been stopped, then the slope would be on both sides of the mattress.For this reason, the bulge as a potential cause of the fall have been ruled out.Based on all collected information and analysis of the photographic evidence, it was concluded that the most likely root cause of the patient¿s fall is usage of the atmosair 9000 mattress with an incompatible bed frame.The mattress retainers of the frame are too narrow for this mattress, which did not allow to place the mattress correctly on the frame.As a result the mattress was laid on the top of mattress retainers instead of being between them.It was confirmed that the dimensional issue does not concern arjo atmosair 9000 mattresses, but the umano bed frame.Arjo device failed to meet its performance specification since patient fell out of it.The device was used for a patient treatment when the failure occurred, therefore it was involved in the event.This complaint is deemed reportable due to allegation of patient's fall from the mattress.Please note that previous medwatch reports for this product may have been submitted under the following registration number: (b)(4).Currently, this product is to be submitted under arjohuntleigh polska sp.Z.O.O.Registration number: (b)(4).
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