MalfunctionFSR
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US
Received Jul 15, 2014 · Event occurred Jun 16, 2014
Report 1222895-2014-00011 · MDR key 4171105
Device
Product problems
- Device Emits Odor
- Device Inoperable
- Failure to Shut Off
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS FAN NOT WORKING, BURNT CABLE SMELL AND WON'T TURN OFF. (B)(6) 2014 CUSTOMER REPORTS THE EVENT OCCURRED NOT LONG AFTER BEGINNING OPEN HEART SURGERY. SURGEON FELT HEAT FROM DEVICE, THERE WAS NO HARM DONE. DEVICE WAS CHANGED OUT IMMEDIATELY, ABOUT 2 MINUTES DELAY.