ALLEN

Description of Event or Problem

BAXTER RECEIVED A REPORT THAT ALLEN FLEX FRAME HAD CFLEX WAS NOT HOLDING ITS POSITION. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

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. UPON INSPECTION, BAXTER FIELD SERVICE TECHNICIAN DETERMINED THAT THE HEADREST WAS OUT OF ADJUSTMENT.A REPAIR WAS COMPLETED TO THE HEADREST. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A MOVEMENT ON THE HOUSING ADAPTER WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.