inforMED
OtherIXW

DENT-X

Received Dec 7, 2006 · Event occurred Sep 1, 2006

Report MW1041305 · MDR key 792581

Device

Generic name

Daylight Loader Model 9992405001 810/9000

Manufacturer

Dent-x

Model number

810/9000

Catalog number

99992405001

Lot number

*

Product problems

  • Design/structure problem
  • Leak/Splash
  • Repair

Patient

*

  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

WE PURCHASED A DENT-X MODEL 9992405001 810/900 DAYLIGHT LOADER FOR OUR NEW DENT-X MODEL 810 X-RAY PROCESSOR. THE DAYLIGHT LOADER WAS INSTALLED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. WHEN WE USED THE LOADER WE FOUND THAT IT HAD A LIGHT LEAK IN THE AREA WHERE IT ATTACHES TO THE PROCESSOR. WE CONTACTED OUR SUPPLIER AND THEY SENT US ANOTHER DAYLIGHT LOADER. WE INSPECTED THE UNIT AND FOUND IT TO HAVE A LIGHT LEAK IN THE SAME AREA. WE CONTACTED THE MANUFACTURER AND THEY DENIED THAT THERE WAS ANY PROBLEM WITH THEIR PRODUCT. INSTEAD THEY BLAMED US FOR AN INCORRECT INSTALLATION. WE MADE PHOTOGRAPHS WHICH CLEARLY DEMONSTRATED THE LIGHT LEAK ON THE NEW, UNINSTALLED UNIT AND SENT THE PHOTOGRAPHS TO THE MANUFACTURER. THEY CONTINUED TO DENY THE EXISTENCE OF A PROBLEM WITH THEIR PRODUCT. WE CONTACTED ONE OF THE DENTAL EQUIPMENT SUPPLIERS WHO HELPS US WHEN WE HAVE SERVICE NEEDS. HE TOLD US THAT HE ALWAYS HAS PROBLEMS WITH THE DENT-X EQUIPMENT, THAT IT IS NOT A GOOD DESIGN, AND THAT HE AVOIDS SELLING IT. WE MADE SUGGESTIONS TO THE MANUFACTURER REGARDING HOW A SIMPLE MODIFICATION WOULD ELIMINATE THE PROBLEM, BUT THEY WERE NOT INTERESTED. WE CONVEYED OUR CONCERNS TO THE PRESIDENT OF DENT-X, BUT WE NEVER RECEIVED A REPLY. WE FEEL THAT THIS PRODUCT PLACES PATIENTS AT RISK FOR UNNECESSARY EXPOSURE TO X-RAY RADIATION DUE TO LIGHT LEAKS WHICH RESULT IN THE NEED FOR DENTAL X-RAY RETAKES.