DUO HEADLIGHT 2 BAY SYSTEM - US
Received Feb 15, 2024
Report 3006697299-2024-00018 · MDR key 18715832
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
Description of Event or Problem
IT WAS REPORTED THAT THE LED HOUSING OF THE DUO HEADLIGHT 2 BAY SYSTEM - US ((B)(6)) HAS PULLED APART AND HAD BECOME AN INFECTION RISK. IN ADDITION, THE RUBBER GROMMET FOR ELECTRICAL CORD IS DRY ROTTED, THE BATTERY HOLDER WAS MISSING A COUPLE OF SLIM NUTS SO THE POWER CONNECTOR ON THE BATTERY PACK CUTS POWER AND OVERHEATS. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT WAS DISCOVERED. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Additional Manufacturer Narrative
THE DUO HEADLIGHT 2 BAY SYSTEM - US ((B)(6)) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE DUO HEADLIGHT WAS RECEIVED IN USED CONDITION. EVALUATION OF THE DUO HEADLIGHT FOUND THAT THE HEADLIGHT LUMINAIRE WAS CRACKED. THUS, THE UNIT WILL BE SENT OUT TO THE MANUFACTURER FOR THE LUMINAIRE REPAIR. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT IS CONFIRMED. EVALUATION IDENTIFIED THAT THE HEADLIGHT LUMINAIRE WAS CRACKED AND REQUIRED REPAIR. THIS IS MOST LIKELY DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.