DUO HEADLIGHT 2 BAY SYSTEM - US
Received Sep 23, 2024 · Event occurred Nov 9, 2023
Report 3006697299-2024-00148 · MDR key 20284286
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
Description of Event or Problem
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM: US (90620US) WAS OVERHEATING AND FLICKERING. THERE WAS NO PATIENT INVOLVEMENT, THUS NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.
Additional Manufacturer Narrative
THE DUO HEADLIGHT 2 BAY SYSTEM, US (90620US) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE RETURNED 90620US DUO HEADLIGHT WAS IN USED CONDITION. THE EVALUATION OF THE DUO HEADLIGHT FOUND THE HEADLIGHT CASE, POWER CORD CONNECTOR, AND THE SNORKEL WERE DAMAGED. THE HEADBAND VELCRO, THE POWER CORD, AND THE SNORKEL HAVE BEEN REPLACED TO CORRECT THE ISSUES. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THE IDENTIFIED DAMAGES WERE MOST LIKELY DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.