DUO HEADLIGHT 2 BAY SYSTEM - US
Received Jul 30, 2024
Report 3006697299-2024-00110 · MDR key 19861424
Device
Product problems
- Overheating of Device
- Output below Specifications
- Overheating of Device
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DUO HEADLIGHT (90620US) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE RETURNED 90620US DUO HEADLIGHT WAS IN USED CONDITION. THE EVALUATION OF DUO HEADLIGHT (90620US) FOUND THAT THE HEADLIGHT SNORKEL AND THE T TUBE WERE DAMAGED. THE SNORKEL AND THE T TUBE WERE REPLACED TO CORRECT THE ISSUES. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THE ISSUE OF THIS 90620US DUO HEADLIGHT DIMMING INTERMITTENTLY WAS MOST LIKELY DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM -US (90620US) DIMS INTERMITTENTLY AFTER BEING USED FOR MORE THAN A FEW MINUTES. THE HEAT EXCHANGER AND FAN WERE CLEANED, IT WAS VERIFIED THE FAN WAS FUNCTIONAL. IT WAS SUSPECTED THAT IT WAS POSSIBLY DUE TO OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT. THUS, NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.