C-FLEX POLAR HEAD POSITNR- DEVICE ONLY

Additional Manufacturer Narrative

THE HEAD POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO SPINE SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. BAXTER TECHNICAL SUPPORT PROVIDED THE ACCOUNT THE PART NUMBER OF THE DEVICE TO RESOLVE THE ISSUE. THE ACCOUNT WILL REPAIR THE BED THEMSELVES. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A MOVEMENT WHILE LOCKED IN POSITION WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HD POS DEVICE ONLY HAD MOVED WHILE IN THE LOCKED POSITION. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.