LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US
Received Aug 16, 2018 · Event occurred Aug 8, 2018
Report 2523190-2018-00103 · MDR key 7790718
Device
Product problems
- Overheating of Device
- Environmental Compatibility Problem
- Overheating of Device
- Environmental Compatibility Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
A CUSTOMER REPORTED THAT ON (B)(6) 2018, A 90520US LED HEADLIGHT WHEN THE FAN KICKS ON THE LIGHT GOES DIM AND THE FAN MAKES A LOT OF NOISE. THE HEADLIGHT GETS OVERHEATED. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT, INJURY AND DELAY IN SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO OTHER CLINICAL INFORMATION RECEIVED.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE COULD NOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE INSPECTION RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE INSPECTION PROCESS.
Description of Event or Problem
N/A.
Description of Event or Problem
N/A.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION OF THE DEVICE INSPECTION RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE INSPECTION PROCESS. A VISUAL INSPECTION OF THE RETURNED LED HEADLIGHT FOUND THE MANIFOLD WAS DETACHED FROM THE LUMINAIRE, THE LEFT FLEX TUBE WAS DETACHED FROM THE MANIFOLD, THE REAR COVER WAS CRACKED ON THE KNOB-SIDE, THE REAR COVER-SCREW BOSS WAS BROKEN ON THE FAN-SIDE AND THE BOSS FOR ONE OF THE FAN SCREWS WAS CRACKED. FUNCTIONAL TESTING FOUND THE UNIT POWERED "ON" AND WAS ADJUSTABLE. ALSO, THE FAN EXCESSIVELY LOUD. NOTE THAT THE LED ENTERS SAFE MODE IN 15 MINUTES TO PROTECT THE LED FROM OVER HEATING DUE TO THE DETACHED COMPONENTS. THE LIGHT INTENSITY GOES DIM IN SAFE MODE. THE LED FAILED SPOT QUALITY. PHYSICAL DAMAGE CONSISTENT WITH ROUGH HANDLING; USER ERROR. THE REPORTED COMPLAINT WAS CONFIRMED.