CFLEX POLAR HD POS DEVICE ONLY

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MAIN PIVOT HINGES SHIFT AND DID NOT HOLD ANY WEIGHT. THERE WAS NO PATIENT INJURY AND THERE WAS NO PROCEDURAL DELAY REPORTED WITH THIS COMPLAINT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

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. 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. THE C-FLEX POSITIONER WAS RECEIVED BY BAXTER. UPON INSPECTION, IT WAS FOUND THAT DEVICE WAS UNABLE TO ADJUST DUE TO LOCTITE BEING PLACED IN THE HOLE AT THE MANUFACTURING PROCESS. A REBUILD AND FINAL TEST OF THE C-FLEX LOWER ARM WAS PERFORMED. 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 C-FLEX POSITIONER NOT HOLDING WEIGHT WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MAIN PIVOT HINGES SHIFT AND DID NOT HOLD ANY WEIGHT. THERE WAS NO PATIENT INJURY AND THERE WAS NO PROCEDURAL DELAY REPORTED WITH THIS COMPLAINT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).