ALLEN

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. THE CFLEX HEAD POSITIONER WAS RECEIVED BY BAXTER. UPON INSPECTION, IT WAS FOUND THAT THERE WAS AN UNWANTED MOVEMENT IN THE PIVOT. THE PIVOT AND THE SCREWS WERE ADJUSTED. 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 CFLEX HEAD POSITIONER HAVING AN UNINTENDED MOVEMENT 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 HEAD POSITIONER WAS NOT HOLDING THE PATIENTS HEAD IN THE LOCK POSITION. THE ISSUE WAS DISCOVERED IN THE OR AFTER PLACING THE PATIENT IN POSITION. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

BAXTER IS IN THE PROCESS OF INSPECTING THE CFLEX HEAD POSITIONER. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER WAS NOT HOLDING THE PATIENTS HEAD IN THE LOCK POSITION. THE ISSUE WAS DISCOVERED IN THE OR AFTER PLACING THE PATIENT IN POSITION. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.