Description of Event or Problem · 1
THE CO2 LASER SYSTEM BEARING SERIAL (B)(4) SHIPPED DIRECTLY TO THIS HOSPITAL BY THE MFR LASER ENGINEERING, INC., USA. THIS UNIT WAS MADE FUNCTIONAL UNDER WARRANTY AFTER REPLACEMENT OF FAULTY CO2 TUBE AND HENE MODULE BY THE SUPPLIER TEAM UNDER VIRTUAL SUPERVISION OF MFR. THEREAFTER 04 TO 05 SURGERIES WERE PERFORMED SUCCESSFULLY. ON MAY 22, 2017, OUR MAINTENANCE AND REPAIR DEPT RECEIVED INTIMATION FOR OUT OF ORDER CO2 LASER SYSTEM INSTALLED AT ENT O.T. OUR BIOMEDICAL TECH / BIO ENGINEER ASSISTANT VISITED THE ENT O.T. DEPT ON THE SAME DAY FOR TROUBLE SHOOTING IN PRESENCE OF O.T.A. ON THE SPOT, IT WAS FOUND THAT UNIT WAS AFFECTED BY FIRE WHICH WAS EXTINGUISHED BY FIRE EXTINGUISHER. LATER ON OUR BIO MEDICAL ENGINEER VISITED THE DEPT AND FOUND THE SAME. THERE WAS NO INFLAMMABLE MATERIAL FOUND NEARBY, SO THERE WAS NO MISHANDLING OR NEGLIGENCE OF CONCERNED PERSONNEL. AS THE MACHINE IS UNDER WARRANTY IT IS REQUESTED TO REPAIR THE MACHINE AS SOON AS POSSIBLE. TWO SIMILAR FIRE INCIDENTS TOOK PLACE DURING THE SAME PERIOD AS MENTIONED IN FDA WARNING LETTER NO (B)(4) TO LEI DATED (B)(6) 2014. WE HAVE BEEN PURSUING THE MFR TO REPAIR AND RETURN THE UNIT DIRECTLY TO (B)(6) GENERAL HOSPITAL (PUBLICLY FUNDED GOVERNMENT HOSPITAL) UNDER WARRANTY WHICH THE MFR IS REFUSING / DELAYING. AS PTS ARE SUFFERING BECAUSE OF INORDINATE DELAY BY MFR TO REMEDY THE SITUATION WE REQUEST FDA TO INTERVENE AND INSTRUCT THE MFR TO IMMEDIATELY REPAIR AND SHIP BACK THE UNIT TO (B)(6) GENERAL HOSPITAL OR GUIDE US TO AN APPROPRIATE PLATFORM WHICH CAN HELP IN RESOLVING THE ISSUE.