inforMED
MalfunctionKLC

NUSTAR DENTAL CHAIR

Received Sep 3, 2013 · Event occurred Aug 7, 2013

Report 1017522-2013-00015 · MDR key 3376662

Device

Generic name

Dental Chair

Manufacturer

Marus

Model number

DC1700

Catalog number

DC1700

Product problems

  • Break
  • Device Tipped Over

Patient

66 YR

  • Fall

Narrative

Additional Manufacturer Narrative

UPON EVAL IT WAS IDENTIFIED THAT THE TWO WELDED SUPPORT BLOCK ON THE FRONT TRUSS ASSEMBLY HAD FAILED AS A RESULT OF IMPROPER WELDING FROM OUR SUPPLIER AS IT WAS NOT WELDED TO MANUFACTURERS SPECIFICATIONS. MARUS CONTACTED THE SUPPLIER OF THE FRONT TRUSS ASSEMBLY TO INFORM THEM OF THIS ISSUE. THE SUPPLIER INFORMED MARUS THAT THEY WILL DEFINE AREAS OF WORK IN PROCESS (WIP) FOR STATUS IDENTIFICATION OF THE WELDING PROCESS. THEY WILL ALSO UPDATE FQC DOCUMENT TO INCLUDE A CONFORMITY CHECK OF WELDMENTS TO ENSURE FRONT TRUSS ASSEMBLIES ARE MANUFACTURED TO MARUS SPECIFICATIONS. ALL FRONT TRUSS ASSEMBLIES THE SUPPLIER HAD IN INVENTORY WERE TO MARUS SPECIFICATIONS. MARUS ALSO CONFIRMED ALL FRONT TRUSS ASSEMBLIES IN HOUSE FROM OUR SUPPLIER WERE TO MANUFACTURERS SPECIFICATIONS.

Description of Event or Problem

A DENTIST HAD POSITIONED A PT FOR TREATMENT IN A LOWERED RECLINED POSITION WHEN THE LIFT ASSEMBLY BROKE ON THE MARUS DC1700 DENTAL CHAIR RESULTING IN THE SEAT ASSEMBLY TO FALL BACKWARDS TOWARDS THE FLOOR WITH THE PT IN THE CHAIR. THE PT VALID OUT OF THE BACK OF THE CHAIR AND ONTO THE FLOOR. THERE WERE NO INJURIES REPORTED.