This report or other informtion submitted by joerns healthcare under 21 cfr part 803, and and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.
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It was reported to the manufacturer, by the end user, per the end user, that patient fell out of bed.Nurse found pt on the floor.Complaint #(b)(4) and (b)(4) were entered into our system to have the mattress and control unit returned for investigation.As of this writing, the units have not been returned.
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