DUO HEADLIGHT 2 BAY SYSTEM - US
Received May 27, 2026
Report 3006697299-2026-00050 · MDR key 25301016
Device
Product problems
- Overheating of Device
- Power Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) HEADLIGHT FAN WAS NOT COMING ON, CAUSING THE HEADLIGHT TO OVERHEAT AND FLICKER. THERE WAS NO PATIENT INJURY, DEATH, OR SURGICAL DELAY REPORTED.
Additional Manufacturer Narrative
THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) WAS NOT AVAILABLE FOR REVIEW. FAILURE ANALYSIS: THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS RECEIVED IN USED CONDITION. THE PROBLEM WAS DUPLICATED AFTER THE DUO HEADLIGHT WAS LEFT RUNNING FOR A WHILE. EVALUATION IDENTIFIED THAT THE POWER SUPPLY WIRE HARNESS, FAN, CONNECTOR BOARD, LENS, AND GROMMET REQUIRED REPLACEMENT, AND WERE REPLACED. THIS IS MOST LIKELY DUE TO ROUTINE USE AND WEAR. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THIS IS MOST LIKELY DUE TO ROUTINE USE AND WEAR. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.