ALLEN LIFT ASSIST BEACH CHAIR

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. THE DEVICE WAS RECEIVED FOR EVALUATION AS THE CUSTOMER DECLINED THE REPAIR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A BEACH CHAIR BACKBOARD BEING CRACKED WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

A DISTRIBUTOR CONTACTED TECHNICAL SERVICE TO REPORT THAT BCH CHR POSITION BEACH CHAIR'S BACK PLATE WAS CRACKED. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.