GS900 CEILING MOUNT

Additional Manufacturer Narrative

THE WELCH ALLYN GS 900 PROCEDURE LIGHT IS DESIGNED TO MEET THE VARIOUS NEEDS OF THE PHYSICIAN¿S OFFICE, HOSPITAL ENVIRONMENT AND SPECIALIST¿S OFFICE. IT IS NOT INTENDED FOR RENDERING DIAGNOSIS OR SURGERY. THE GS 900 LIGHT IS MOUNTED ON A MOBILE STAND, CEILING MOUNT OR WALL MOUNT. THE DEVICE HAS NOT YET BEEN RECEIVED FOR INSPECTION. A REPLACEMENT CEILING MOUNT WAS SENT TO THE CUSTOMER. 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 MISSING INTERNAL SCREW IN THE CEILING MOUNT WERE TO RECUR, THE UNIT COULD POTENTIALLY FALL AND CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE CEILING MOUNT FOR THEIR GS900 HAS BROKEN A SCREW INTERNALLY. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #(B)(4).