C-FLEX POLAR HEAD POSITIONER

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER DEVICE WAS NOT HOLDING ITS POSITION. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

BAXTER IS IN THE PROCESS OF INSPECTING THE C-FLEX 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.

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 TECHNICIAN FOUND EXCESSIVE RUST IN EACH OF THE THREE MAIN JOINTS AND DETERMINED TO REPLACE MOST OF THE INTERNAL PARTS. AFTER REPLACING ALL OF THE BEARING ASSEMBLIES, ONE OF THE KNOB ASSEMBLIES, BALL HALVES, WOODRUFF KEYS, CENTER SHAFT, AND BELLEVILLE COMPONENTS, C-FLEX HEAD POSITIONER WAS WORKING AS DESIGNED. 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 C-FLEX HEAD POSITIONER NOT HOLDING 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 DEVICE WAS NOT HOLDING ITS POSITION. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.