ERGOLINE
Received May 28, 2015 · Event occurred Apr 24, 2015
Report 2311923-2015-00001 · MDR key 4808790
Device
Generic name
Suntan Bed
Manufacturer
Jk Products & ServicesModel number
AMBITION 300Catalog number
NA
Lot number
NA
Product problems
- Inadequate or Insufficient Training
- Improper or Incorrect Procedure or Method
Patient
34 YR
- Injury
Narrative
Description of Event or Problem
INJURY TO FINGERS WHEN THEY WERE ALLEGEDLY INSERTED INTO THE FOOT FAN.
Additional Manufacturer Narrative
THIS TANNING APPLIANCE MODEL HAS BEEN TESTED WHERE APPLICABLE AND FOUND TO BE IN COMPLIANCE WITH UNDERWRITERS LABORATORY STANDARDS UL (B)(4) LUMINARIES, UL (B)(4) PORTABLE SUN/HEAT LAMPS, AND UL (B)(4) COMMERCIAL REFRIGERATORS AND FREEZERS. THIS TESTING RESULTED IN THE LISTING AND APPROVAL TO BE MARKED WITH THE INTERTEK TESTING SERVICES (ETL) CERTIFICATION (REPORT NUMBER (B)(4)). THIS INCIDENT HAS BEEN INVESTIGATED TO THE FULLEST EXTENT POSSIBLE GIVEN THE INFORMATION PROVIDED AND ONLY LIMITED ACCESS TO SAID TANNING APPLIANCE BY THE SALON, DUE TO THE ANTICIPATION OF A LIABILITY CLAIM BEING FILED BY THE INJURED CUSTOMER. OUR FINDINGS SHOW THAT AS PRODUCED THE FAN GRILL PROVIDES PROPER PROTECTION FROM INADVERTENT CONTACT WITH THE FAN. THE LACK OF EVIDENCE I.E. BLOOD AND INABILITY TO LOCATE THE MISSING APPENDAGES, RAISES QUESTION AS TO THE EXACT ACCOUNT OF HOW THE INCIDENT OCCURRED. OUR INVESTIGATION CONCLUDES THAT GIVEN THE STANDARDS USED TO TEST AND EVALUATE OUR PRODUCT, PLUS THE SMALL OPENINGS OF THE FAN GRILL AND PROXIMITY OF THE FAN BLADES TO THE GRILL, COMBINED WITH THE FACT THAT THE FAN IS LOCATED AT THE FOOT END OF THE BED AND BEING THE FURTHEST MOST POINT FROM THE USER CONTROLS INCLUDING THE START/STOP BUTTON. THEREFORE WE ARE CONFIDENT THE INCIDENT WAS NOT CAUSED BY THE DEVICE, AND CONCLUDE THE INCIDENT WAS A RESULT OF IMPROPER USE AND/OR MODIFICATION OF THE FAN FROM ITS AS PRODUCED STATE.