DUO HEADLIGHT 2 BAY SYSTEM - US
Received May 13, 2024
Report 3006697299-2024-00059 · MDR key 19303491
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 2 BAY SYSTEM WAS RECEIVED IN USED CONDITION. THE DEPOT TECHNICIAN COMPLETED THE EVALUATION OF THE DUO HEADLIGHT AND IDENTIFIED THAT THE HEADLIGHT HAD LOOSE DEBRIS INSIDE THE LUMINAIRE AND THE RING RETAINING THE LENS WAS IN PLACE BUT NOT ABLE TO ADJUST THE LIGHT SMALL SPOT SIZE. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THE ISSUE WAS MOST LIKELY DUE TO ROUTINE USE AND WEAR. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS OVERHEATING, CAUSING THE FAN TO FLICKER. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.