DUO HEADLIGHT 2 BAY SYSTEM - US

Additional Manufacturer Narrative

THE SUSPECTED DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: THE DEPOT TECHNICIAN FOUND THAT DURING EVALUATION OF THE DUO HEADLIGHT, THE UNIT FAILED THE SPOT SIZE AND UNIFORMITY TEST. THE TECHNICIAN ALSO NOTED THAT THE FAN WAS NOT WORKING PROPERLY. THE DUO HEADLIGHT WILL BE SENT TO THE SUPPLIER FOR REPAIR AND RETURNED TO THE CUSTOMER. ROOT CAUSE ANALYSIS: THE RETURNED DUO HEADLIGHT WAS IN USED CONDITION WITH A FAILING/DAMAGED LUMINAIRE DUE TO WEAR. THE COMPLAINT REPORTED BY THE CUSTOMER WAS 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.

Description of Event or Problem

A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) STARTED BLINKING. THE BIOMEDICAL TECHNICIAN VERIFIED THAT AFTER A FEW MINUTES THE LAMP ALTERNATES BETWEEN DIM AND BRIGHT. THE TECHNICIAN OBSERVED WHAT SEEMED TO BE EXCESSIVE HEAT AND THE COOLING FAN OPERATION COULD NOT BE SEEN NOR HEARD. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.