GS-900 PROC.LT W/CEILING MOUNT

Description of Event or Problem

THE CUSTOMER REPORTED HEARING AN AUDIBLE SPARK WITHIN THE GS-900 ARM. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

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 GREEN SERIES 900 LIGHT WAS RECEIVED BY BAXTER. UPON INSPECTION, IT WAS DETERMINED THAT THE INTERNAL POWER CORD WIRING HAD MELTED AND OVERHEATED MARKS. A REPLACEMENT OF THE DEVICE 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 SPARK IN THE DEVICE WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.