This report or other information 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 on 10/2323 an ecmo patient rolled out of their bariatric bed and fell onto the floor resulting in a dislodged line, requiring additional treatment.The cause of the fall is unknown at this time.Once the patient was assisted back into the bed, nursing noticed one of the air cells had been deflated.Complaint # (b)(4) and ra #84093826 were entered into our system to have the device returned for investigation.As of this writing, the units have not been returned.
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