DUO HEADLIGHT 2 BAY SYSTEM - US
Received Oct 27, 2025
Report 3006697299-2025-00121 · MDR key 23393807
Device
Product problems
- Overheating of Device
- Intermittent Energy Output
- Overheating of Device
- Intermittent Energy Output
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) FAN WAS NOT WORKING AND OVERHEATING, MAKING THE LIGHT FLICKER. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY REPORTED.
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.
Additional Manufacturer Narrative
UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE RETURNED 90620US DUO HEADLIGHT WAS IN USED CONDITION. THE 90620US DUO HEADLIGHT 2 BAY SYSTEM EVALUATION COULD NOT REPLICATE CUSTOMER CUSTOMER-STATED ISSUE; THE FAN APPEARS TO FUNCTION PROPERLY; HOWEVER, THE EVALUATION IDENTIFIED THAT THE POWER CORD WAS BROKEN, WHICH TURNS THE LIGHT OFF. THE ISSUES OF THE UNIT OVERHEATING OR THE FAN MALFUNCTIONING COULD NOT BE DUPLICATED. THE ISSUE OF THE UNIT FLICKERING WAS MOST LIKELY DUE TO THE DAMAGED POWER CABLE. THE REPORTED COMPLAINT IS CONFIRMED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ROOT CAUSE ANALYSIS - THE REPORTED COMPLAINT WAS CONFIRMED. THE EVALUATION IDENTIFIED THAT THE POWER CORD IS BROKEN AND TURNS THE LIGHT OFF. THIS IS MOST LIKELY DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE ISSUES OF THE UNIT OVERHEATING OR THE FAN MALFUNCTIONING COULD NOT BE DUPLICATED. THE ISSUE OF THE UNIT FLICKERING IS MOST LIKELY DUE TO THE DAMAGED POWER CABLE.
Description of Event or Problem
N/A.