BEACH CHAIR POSITIONER

Additional Manufacturer Narrative

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 DURING A TOTAL SHOULDER PROCEDURE, A BEACH CHAIR POSITIONER HYDRAULIC CYLINDER BROKE, AND THE PATIENT IMMEDIATELY RECLINED AND FELL FLAT. THE PATIENT WAS UNINJURED, AND THE PROCEDURE WAS FINISHED WITHOUT INCIDENT. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

Additional Manufacturer Narrative

THE BEACH CHAIR SHOULDER POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD AND TORSO IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO ORTHOPEDIC SURGERIES LIKE, ROTATOR CUFF, TOTAL SHOULDER, REVERSE TOTAL SHOULDER, SLAP REPAIR AND OTHER SHOULDER SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. CUSTOMER REFUSED TO RETURN THE ASSOCIATED DEVICE AND THEREFORE NO ROOT CAUSE WAS ABLE TO BE DETERMINED. 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 HYDRAULIC CYLINDER BREAKAGE WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.