It was reported to the manufacturer, by the end user, per the end user, that received an email from wcn at (b)(6) that a patient incident occurred on an agiliti rental.The patient ws being prepped for hospice and fell out of bed which resulted in death.Complaint #(b)(4) and ra #(b)(4) was entered into our system to have the mattress and control unit returned for investigation.
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This report or other information submitted by joerns healthcare under 21 cfr part 803, 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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