DUO HEADLIGHT 2 BAY SYSTEM - US
Received Apr 17, 2025 · Event occurred Mar 7, 2025
Report 3006697299-2025-00040 · MDR key 21854924
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
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) STARTS TO "FLICKER AND GETS PRETTY HOT," AFTER BEING ON FOR A WHILE. IT WAS ALSO REPORTED THAT THE FAN WAS NOT RUNNING, "POSSIBLY OVERHEATING." THE DEVICE WAS NOT IN CONTACT WITH A PATIENT. NO PATIENT INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.
Additional Manufacturer Narrative
THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE DUO HEADLIGHT 2 BAY SYSTEM - US WAS RECEIVED IN USED CONDITION. THE EVALUATION IDENTIFIED THAT THE HEADLIGHT POWER CORD CONNECTOR WAS SHORT-CIRCUITED LEADING TO THE LIGHT FLICKERING. THE HOLSTER SCREW WAS NOT TIGHTENED PROPERLY. 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 SHORT, AND THE LOW VOLTAGE WOULD NOT CAUSE A HAZARD. TO RESOLVE THESE ISSUES, THE POWER CORD AND HOLSTER WERE REPLACED. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THE REPORTED ISSUE WAS MOST LIKELY DUE TO ROUTINE USE AND WEAR. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.