DUO HEADLIGHT 2 BAY SYSTEM - US

Description of Event or Problem

IT WAS REPORTED THAT A LOANER DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS RETURNED FROM A FACILITY AND NEEDED TO BE SERVICED. A SPECIFIC FAULT WAS NOT REPORTED. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. AFTER THE DEVICE WAS RETURNED BY THE CUSTOMER, EVALUATION SHOWED THAT THE POWER CORD ON THE UNIT HAS A SHORT.

Additional Manufacturer Narrative

THE DUO HEADLIGHT (90620US) WAS RECEIVED BY THE MANUFACTURER¿S SERVICE AND REPAIR DEPOT: DEVICE HISTORY RECORD (DHR): THE DHR WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. FAILURE ANALYSIS: THE DEPOT TECHNICIAN ASSESSMENT FOUND THAT THE POWER CORD ON THE UNIT HAD A SHORT AT THE END OF THE CORD THAT WAS CAUSING THE LIGHT TO FLICKER OFF/ON WHENEVER THE CORD WAS MOVED. THE POWER CORD WAS REPLACED TO CORRECT THIS ISSUE. NO OTHER ISSUES WERE FOUND WITH THE LOANER UNIT.ROOT CAUSE ANALYSIS: EVALUATION IDENTIFIED A DAMAGED/SHORTED POWER CORD DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT 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. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.