HDS, PATIENT PLATFORM

Additional Manufacturer Narrative

THE HIP DISTRACTOR SYSTEM IS DESIGNED TO POSITION, SUPPORT AND/OR DISTRACT THE PATIENT¿S HIP, POSTERIOR LOWER TORSO AND FOOT FOR HIP SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. THE BAXTER TECHNICIAN FOUND EXCESSIVE DAMAGE SHOWING SIGNS OF EITHER BEING DROPPED OR MISUSED. IT WAS NOTED THAT MANY COMPONENTS EITHER BROKEN BENT OR GOUGED. BAXTER TECHNICAL SERVICE PROVIDED THE ACCOUNT THE ESTIMATES ON REPAIRS, HOWEVER THE ACCOUNT HAS DECLINED REPAIR. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORTED EVENT 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 HDS PATIENT PLATFORM HAD HDS PATIENT PLATFORM HAD A PIECE FROM THE CENTRAL AREA WHERE THE SUPPORT SLIDES DETACH. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.