(b)(4) is the initial importer of the device which is a half bed rail.This bed rail was paired initially paired with an invacare mattress.The end-user was coded to hospice care.A new third party service provider for hospice care delivered a drive air mattress model 14027 to replace the invacare mattress.The delivery was supposed to include a peri cover that did not arrive with the mattress.No other changes were made to the setup.Per summons, despite noticing a new mattress, the staff did not perform a new bed rail safety assessment.It was reported that patient was immobile and incontinent.The next morning the patient was found entrapped between the mattress and the rail.
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