IND300 10ININ SINGLE ARM CEILING LIGHTIN

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE D300 ARM CAME DETACHED FROM THE HORIZONTAL ARM OF THE TC CHROMOPHARE SUSPENSION. THERE WERE NO REPORTS OF ANY INJURY OR ADVERSE CONSEQUENCES. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED FOR INVESTIGATION. DURING HIS ONSITE VISIT, THE SFST NOTED THAT THE HOSPITAL BIOMED DE-INSTALLED THE EXAM LIGHT WITH NO INCIDENT PRIOR TO HIS ARRIVAL. WHILE INSPECTING THE EQUIPMENT THERE WAS NO DAMAGE NOTED ON THE SPRING ARM OR EXAM LIGHT. HE THEN INSPECTED THE ADAPTER THAT FITS THE D300 SPRING ARM ONTO THE HORIZONTAL ARM OF THE CHROMOPHARE SUSPENSION AND NOTED THAT CIRCLIP THAT HOLDS THE ADAPTER TO THE SPRING ARM HAD FALLEN OUT. THE D300 EXAM LIGHT WAS REINSTALLED WITH A NEW CIRCLIP AND WASHER AND FUNCTIONAL TESTING WAS PERFORMED. THE DEVICE WAS FOUND TO BE WORKING TO SPECIFICATION AND WAS PLACED BACK INTO SERVICE. THE D300 EXAM LIGHT SYSTEM WAS OBSOLESCED IN FEBRUARY 2018. BASED ON THE REPORTED SERIAL NUMBER, THE EXAM LIGHT SYSTEM WAS MANUFACTURED IN YEAR 2012. THERE WAS NO INSTALLATION QIP FOUND FOR THE EXAM LIGHT, SO IT IS UNCLEAR IF THE SYSTEM WAS INSTALLED BY STRYKER OR THE CUSTOMER.ALTHOUGH THE EXACT ROOT CAUSE OF THIS ISSUE IS UNKNOWN, THE MOST LIKELY ROOT CAUSE WOULD BE IMPROPER SERVICE AND MAINTENANCE BY HOSPITAL PERSONNEL AS OUTLINED IN THE CHROMOPHARE F300 EXAM LIGHT OPERATING MANUAL, PART #57363, REVISION J, SECTIONS 9.3 AND 9.4 . IF ANY FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT IN MICU ROOM 1070 D300 ARM CAME DETACHED FROM THE HORIZONTAL ARM OF THE TC CHROMOPHARE SUSPENSION. PER INVESTIGATION, THE CIRCLIP THAT HOLDS THE ADAPTER TO THE SPRING ARM HAD FALLEN OUT. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.