MalfunctionLEJ
ERGOLINE
Received Jul 11, 2018 · Event occurred Jun 15, 2018
Report 9615023-2018-00001 · MDR key 7679344
Device
Product problems
- Fire
- Use of Device Problem
- Use of Device Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
AFTER USE OF THE DEVICE INDICATED, THE USER REPORTED SMOKE COMING FROM THE HOUSING OF THE SHOULDER TANNER BULB. IN AN ATTEMPT TO IDENTIFY THE SOURCE OF THE SMOKE THE MANAGER OF THE SALON COMPROMISED THE HOUSING BY PUSHING IN ON THE GLASS, RESULTING IN A SMALL FLAME STARTING WHERE THE GLASS SEPARATED FROM THE HOUSING. THE SMALL FLAME WAS QUICKLY EXTINGUISHED WITHOUT INCIDENT.
Additional Manufacturer Narrative
RISK ANALYSIS REPORT AND INVESTIGATION REPORT ADDED.