DUO HEADLIGHT 2 BAY SYSTEM - US
Received Mar 23, 2026 · Event occurred Jan 20, 2026
Report 3006697299-2026-00026 · MDR key 24661781
Device
Product problems
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 IDENTIFIED THAT THE HEADLIGHT POWER CORD CONNECTOR WAS SHORT-CIRCUITING, CAUSING THE FAN TO STOP, RESULTING IN THE UNIT OVERHEATING. THE ISSUE OF A ¿SHORT"REFERS TO A POOR CONNECTION OF THE POWER PINS THAT CAN POTENTIALLY RESULT IN A FAILING CONNECTION TO THE BATTERY PORT. NO RISK OF HARM WOULD BE INCURRED BY THIS TYPE OF SHORT, AND THE LOW VOLTAGE WOULD NOT CAUSE A HAZARD." ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THE REPORTED ISSUE WITH THIS 90620US DUO HEADLIGHT WAS MOST LIKELY DUE TO ROUTINE USE AND WEAR. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
A FACILITY REPORTED THAT THE PRODUCT DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) LIGHT WAS PULSING WHEN IN OPERATION, SIGNIFYING THAT IT WAS PROBABLY OVERHEATING, AS THE FAN ON TOP WAS NOT SPINNING ANYMORE. THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURIES OR SURGICAL DELAYS WERE REPORTED.