DUO HEADLIGHT AND CARRYING CASE
Received Aug 4, 2024 · Event occurred Jul 12, 2024
Report 3006697299-2024-00113 · MDR key 19902957
Device
Product problems
- Overheating of Device
- Power Problem
- Overheating of Device
- Power Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATED FIELDS - D4 (UDI), D9, G3, G6, H2, H3, H6, H11. THE DUO HEADLIGHT AND CARRYING CASE (90600) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - EVALUATION IDENTIFIED THAT THE HEADLIGHT POWER CORD CONNECTOR WAS SHORTED. THE ISSUE OF A "SHORT" REFERS TO 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. THIS WAS MOST LIKELY DUE TO ROUTINE USE AND WEAR. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
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
IT WAS REPORTED THAT THE DUO HEADLIGHT AND CARRYING CASE (90600) HAS A COOLING FAN ISSUE. THE FAN DOES NOT COME ON, OVERHEATS THE LIGHT AND TURNS OFF. THERE WAS NO PATIENT INVOLVEMENT, THUS NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.