HEXALUX

Additional Manufacturer Narrative

THE SHELF COMPONENT SUBJECT TO THE REPORTED EVENT HAS BEEN DISCARDED, AND THE USER FACILITY REQUESTED A REPLACEMENT SHELF. THE DAMAGE IS INDICATIVE OF FACILITY PERSONNEL ALLOWING THE DEVICE TO CONTACT THE WALL WITH SUFFICIENT FORCE TO BREAK THE SHELF. THE OPERATOR MANUAL STATES, "AVOID HANDLING THE SUSPENSION ROUGHLY, PARTICULARLY EXCESSIVE SHOCKS AGAINST THE END OF TRAVEL STOP. DO NOT BUMP THE LIGHTHEAD INTO WALLS OR OTHER EQUIPMENT. ALWAYS USE HANDLES WHEN POSITIONING THE LIGHTHEAD DURING EXAMINATION PROCEDURES, OR WHEN CLEANING OR SERVICING THE EXAMINATION LIGHTING SYSTEM. MOVING THE MOBILE STAND: BEFORE MOVING THE EQUIPMENT, ENSURE THE PATH IS FREE OF OBSTACLES. MOVE THE MOBILE BASE FLOOR STAND CAREFULLY. ADAPT THE SPEED TO THE ENVIRONMENT (CORRIDOR WIDTH, CORNER ANGLES, DOORS, ETC...)" THE STERIS ACCOUNT MANAGER COUNSELED THE USER FACILITY PERSONNEL ON NOT BUMPING THE DEVICE INTO WALLS OR OTHER EQUIPMENT. A THREE-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE SHELF COMPONENT OF THEIR HEXALUX EXAMINATION LIGHT MADE CONTACT WITH THE WALL AND CRACKED CREATING A SHARP EDGE. THE SHARP EDGE CAUSED A MINOR CUT TO A NURSE'S HAND. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (BANDAGES). NO REPORT OF PROCEDURAL DELAY.