DUO HEADLIGHT 2 BAY SYSTEM - US

Description of Event or Problem

A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) HAD A LOOSE CONNECTION; THE LIGHT SHUTS OFF. IT WAS REPORTED THAT THE LIGHT WORKS ONLY WHEN THE WIRE IS CRAMMED IN THE UNIT AND CRANKED DOWN TIGHT. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY HAS BEEN REPORTED. AFTER THE DEVICE WAS RETURNED BY THE CUSTOMER, EVALUATION SHOWED THAT THE POWER CORD HAS AN SHORT AT THE END OF THE CORD.

Additional Manufacturer Narrative

THE DUO HEADLIGHT (90620US) WAS RECEIVED BY THE MANUFACTURER¿S SERVICE AND REPAIR DEPOT. FAILURE ANALYSIS: EVALUATION OF THE DUO HEADLIGHT FOUND THAT THE POWER CORD HAD A SHORT AT THE END OF THE CORD WHICH WAS CAUSING THE LIGHT TO FLICKER OFF AND ON WHENEVER THE CORD WAS MOVED. THE POWER CORD HAS BEEN REPLACED TO CORRECT THIS ISSUE. ROOT CAUSE ANALYSIS: EVALUATION IDENTIFIED DAMAGE TO THE POWER CORD DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT IS CONFIRMED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.