MalfunctionFSR
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US
Received Feb 19, 2015 · Event occurred Jan 27, 2015
Report 1222895-2015-00005 · MDR key 4535955
Device
Product problems
- Device Emits Odor
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER INITIALLY REPORTS THAT HE HAD AN LED UNIT THAT WAS NO LONGER WORKING. THE UNIT'S BACK SWITCH WHERE YOU CAN ADJUST INTENSITY DOES NOT ALLOW THE LIGHT TO BE TURNED OFF. ALSO, THE OPERATING ROOM REPORTED A FUNNY SMALL COMING FROM THE UNIT WHEN TURNED ON. A SMOKY SMELL LIKE SOMETHING WAS BURNING (B)(6) 2015 NO HARM DONE, NO FURTHER INFORMATION AVAILABLE.
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.