DUO HEADLIGHT 2 BAY SYSTEM - US
Received Dec 6, 2024 · Event occurred Oct 21, 2024
Report 3006697299-2024-00170 · MDR key 20861393
Device
Product problems
- Overheating of Device
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE DUO HEADLIGHT WAS RECEIVED IN USED CONDITION. THE DEPOT TECHNICIAN DUPLICATED THE PROBLEM REPORTED BY THE CUSTOMER. EVALUATION IDENTIFIED THAT THE LUMINAIRE WAS OVERHEATING, LEADING TO THE LIGHT FLICKERING. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THE FAILURE WAS MOST LIKELY DUE TO DAMAGE TO THE FAN INSIDE THE HEADLIGHT, CAUSED BY ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
IT WAS REPORTED THAT THE LIGHT OF THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) FLICKERS ABOUT AN HOUR AFTER USE, AND THE LIGHT WAS GETTING HOT. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO PATIENT INJURY, DEATH OR SURGICAL DELAY OCCURRED.