SUNQUEST
Received Jun 10, 1999 · Event occurred Apr 22, 1999
Report MW4002531 · MDR key 226843
Device
Generic name
Tanning Bed
Manufacturer
Spectrum Products, Inc.Model number
PRO 24S SUNTAN BEDCatalog number
*
Lot number
*
Product problems
- Collapse
- Component Falling
- Component(s), worn
Patient
UNKNOWN
- Other (for use when an appropriate patient code cannot be identified)
- Numbness
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
COMPLAINANT STATES THAT THE BED TOP COLLAPSED ON HER WHILE SHE WAS TANNING. THE COMPLAINANT STATES THE BOLTS THAT HOLD THE LID WERE RUSTED. THE LID FELL ON HER BACK. SHE SAID SHE HAD TO PHYSICALLY PUSH IT OFF TO GET OUT OF THE BED. SHE INDICATED THAT HER BACK AND NECK WERE NUMB FOR 1.5 DAYS. HER PHYSICIAN FELT SHE HAD PULLED A MUSCLE. ON 5/12/99, INVESTIGATOR CONTACTED THE FACILITY, WHO SAID A SHOCK HAD GONE OUT ON ONE END OF THE LID. FURTHER, BECAUSE THE LID WAS HEAVY, THE OTHER SHOCK WAS UNABLE TO SUPPORT THE WEIGHT OF THE LID, CAUSING IT TO DROP. STAFF HAVE CHECKED ALL OF THEIR SUNTAN BEDS AND ROUTINE PREVENTATIVE MAINTENANCE HAS BEEN PERFORMED. NO SIMILAR PROBLEMS WERE NOTED. ON 5/14/99, INVESTIGATOR SPOKE WITH FACILITY REP. HE PROVIDED THE REQUESTED INFO. ADDITIONALLY, HE SAID THE PART WHERE THE SHOCK ATTACHES TO THE BED HAD WORN OUT. HE FELT IT WAS SIMPLY WEAR AND TEAR SINCE THE REFERENCED BED HAS BEEN IN USE SINCE 8/92. HE SAID HE CONTACTED THE MFR AND WAS TOLD THEY HAVE A NEWER END IN PRODUCTION AND THAT THEY NO LONGER MAKE THAT PART. NO FURTHER FOLLOW-UP WAS MADE.