SKYTRON

Additional Manufacturer Narrative

SKYTRON SENT THE LOCAL DISTRIBUTOR TO THE FACILITY TO ASSESS THE SITUATION. HE RECEIVED CONFLICTING INFORMATION FROM THE MEDICAL STAFF IN THE OR. WE WILL CONTINUE TO MONITOR THE SITUATION AND SEND THE FDA UPDATES AS WE RECEIVE THEM.

Description of Event or Problem

A PATIENT, HAD AN OPEN HEART SURGERY PROCEDURE WITH PATIENT REVERSED ON THE TABLE. PATIENT'S CHEST BEGAN TO FILL WITH FLUID, SO THE ANESTHESIOLOGIST PUT TABLE IN REVERSE TRENDELENBURG POSITION. ACCORDING TO THE STAFF, THE TABLE BEGAN TO TIP TOWARDS ANESTHESIA. WHILE ATTEMPTING TO PREVENT THE PATIENT FROM FALLING, TWO MALE STAFF MEMBERS LEANED ON TABLE AND GRABBED PATIENT. THE PATIENT WAS NOT RESTRAINED WHILE ON THE TABLE AND NOBODY SAW THE FEET OF THE TABLE ACTUALLY LIFT OFF THE FLOOR. THE INCIDENT OCCURRED AT: THE MEDICAL CENTER.