This report or other informtion 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.
|
It was reported to the manufacturer, by the end user, per the end user, that patient was on a dolphin mattress and blower, units malfunctioned, and the patient was on the frame.Units were swapped out for a different dolphin mattress and blower which led to another malfunction and the patient was on the frame again.Complaint (b)(4) and ra (b)(4) were entered into our system to have the units returned for investigation.As of this writing, the units have not been returned.
|