DUO HEADLIGHT 2 BAY SYSTEM - US
Received Jun 7, 2024 · Event occurred May 15, 2024
Report 3006697299-2024-00077 · MDR key 19487243
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
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
A FACILITY REPORTED THAT THERE WAS A LIGHT MALFUNCTION WITH THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US). THE LIGHT WOULD "FLICKER" DUE TO THE TOP COOLING FAN NOT WORKING. THE DUO HEADLIGHT WOULD OPERATE NORMALLY FOR THE FIRST TEN MINUTES, THEN PROCEED TO ¿FLICKER¿ WHEN THE MODULE BECAME HOT. IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGERY AS A REPLACEMENT DEVICE WAS AVAILABLE FOR USE. NO PATIENT INJURY WAS REPORTED.
Description of Event or Problem
N/A.
Additional Manufacturer Narrative
UPDATED FIELD: D4 (UDI#), D9, G3, G6, H2, H3, H11. THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE SUSPECTED DUO HEADLIGHT 2 BAY SYSTEM WAS RECEIVED IN USED CONDITION. EVALUATION OF THE DUO HEADLIGHT IDENTIFIED THAT THE HEADLIGHT POWER CORD CONNECTOR PIN WAS BROKEN OFF. THE POWER CORD HAS BEEN REPLACED TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTS. ROOT CAUSE ANALYSIS - THE REPORTED COMPLAINT WAS CONFIRMED. IT WAS DETERMINED THAT THE ISSUE WAS MOST LIKELY DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.