Description of Event or Problem · 1
DURING A LUNG SCAN, PATIENTS WERE COMPLAINING THAT THE BIODEX PULMONEX SYSTEM HAD A STRONG ODOR AND SAID THAT IT WAS BURNING THEIR LUNGS. BIODEX WAS CONTACTED ON THE DAY WHEN THE ISSUE WAS FIRST REPORTED. THE INITIAL FEEDBACK FROM BIODEX WAS THE SYSTEM MAY HAVE BEEN CONTAMINATED SO WE WERE INSTRUCTED TO FLUSH THE SYSTEM WITH OXYGEN. WHEN THIS DID NOT CORRECT THE PROBLEM WE WERE TOLD THE NEXT STEP WOULD BE TO REPLACE THE HOSES, VALVE, AND BAGS. I WAS ASKED TO SUPPLY THE NAME OF THE VENDORS AND THE LOT NUMBERS OF THE CHEMICALS BEING USED. THIS INFORMATION WAS EMAILED TO BIODEX ON THE DAY AFTER THE EVENT. ON THE SECOND DAY AFTER THE EVENT, I HAD NOT YET RECEIVED THE PART NUMBERS FOR THE PARTS I WAS TOLD TO REPLACE SO I CONTACTED BIODEX. I WAS NOW TOLD THE PARTS WOULD NOT FIX THE PROBLEM AND THIS WAS OCCURRING AT 10 OTHER SITES. BECAUSE I HAD NO PROGRESS TOWARDS A RESOLUTION BY THE THIRD DAY, I ALSO ON THAT SAME DAY HAD SENT AN EMAIL REQUESTING AN ACTION PLAN AND A TIMELINE FOR THE ACTION PLAN. NO RESPONSE FROM THE MANUFACTURER WAS RECEIVED REGARDING THIS EMAIL. I WAS TOLD ON DAY THREE OF THE ISSUE OCCURRING THAT THE ISSUE WAS BEING INVESTIGATED BY AN OUTSIDE ENVIRONMENTAL CONTRACTOR AND I WOULD HAVE TO WAIT FOR THE RESULTS. ON THE FOURTH DAY, I HAD NOT RECEIVED ANY STATUS UPDATE SO I AND THE DEPARTMENT MANAGER CALLED THE VENDOR FOR A STATUS ON THE ACTION PLAN AND WE WERE TOLD THERE WAS NO UPDATE AVAILABLE. LATER ON THE FOURTH DAY, I RECEIVED A STATUS CALL OF, "NO STATUS CHANGE". ON DAYS SIX AND SEVEN OF THE EVENT, THERE WAS NO STATUS REPORTED NOR WAS THERE A STATUS UPDATE. I CALLED BIODEX AND ARRANGED A CALL WITH BIODEX, CLINICAL ENGINEERING MANAGEMENT, AND THE RADIOLOGY DIRECTOR. ON DAY 11 WE WERE TOLD NO CAUSE HAD YET BEEN DETERMINED AND THEY WERE WAITING FOR THE RESULTS FROM THE THIRD PARTY COMPANY. THEY AGREED TO SEND US AN ALTERNATE SOLUTION.======================MANUFACTURER RESPONSE FOR XENON SYSTEM, PULMONEX (PER SITE REPORTER).======================THEY SENT SAMPLES FROM OTHER CUSTOMERS EXPERIENCING THIS SAME PROBLEM TO A 3RD PARTY ENVIRONMENTAL TESTING COMPANY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LUNG SCAN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.