DUO HEADLIGHT 2 BAY SYSTEM - US
Received Nov 17, 2025 · Event occurred Oct 22, 2025
Report 3006697299-2025-00132 · MDR key 23576764
Device
Product problems
- Melted
- Melted
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 THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) HAD A MELTING MARK ON THE COVER OF THE BAND ADJUSTING GEAR. IN ADDITION, THE CABLE WAS ALMOST PULLED OUT OF THE DEVICE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED, AND NO DELAY HAS BEEN REPORTED.
Additional Manufacturer Narrative
UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE DEFINITE ROOT CAUSE CANNOT BE IDENTIFIED AS THE DEVICE WAS NOT RETURNED. BASED ON THE REPORTED COMPLAINT, THE PROBABLE ROOT CAUSE FOR THIS 90620US DUO HEADLIGHT HAVING SIGNS OF MELTING IS DUE TO OVERHEATING CAUSED BY A MALFUNCTIONING FAN. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, CONSIDER THIS COMPLAINT TO BE CLOSED.
Description of Event or Problem
N/A.