DUO HEADLIGHT 2 BAY SYSTEM - US
Received Nov 28, 2025 · Event occurred Oct 8, 2025
Report 3006697299-2025-00134 · MDR key 23673972
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 (ID 90620US) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE DUO HEADLIGHT 2 BAY SYSTEM - US WAS RECEIVED IN USED CONDITION. THE EVALUATION COULD NOT DUPLICATE ANY ISSUES WITH THE 90620US DUO HEADLIGHT MALFUNCTIONING. THE CUSTOMER DID NOT RETURN THE BATTERY HOLSTER FOR INSPECTION. THE ISSUE OF THE UNIT TURNING OFF ALLEGEDLY DUE TO OVERHEATING COULD BE DUE TO A MALFUNCTIONING BATTERY HOLSTER. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ROOT CAUSE ANALYSIS - THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE ISSUE OF THE UNIT TURNING OFF ALLEGEDLY DUE TO OVERHEATING COULD BE DUE TO A MALFUNCTIONING BATTERY HOLSTER.
Description of Event or Problem
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) OVERHEATED AND SHUT OFF DURING A PROCEDURE. IT WAS STATED THAT THE FAN MAY NOT BE FUNCTIONING PROPERLY. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED.