BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODUTEC

    MDR report key: 2773140 · Received September 27, 2012

    Report

    Report Number
    2773140
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MAQUET
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    AFTER THE CEILING SUPPLY UNITS WERE INSTALLED IN A HYBRID OR, A MEDICAL GAS CERTIFICATION COMPANY ATTEMPTED TO CERTIFY THEM. THEY COULD NOT GET THE NITROUS OXIDE LINES ON BOTH UNITS TO PASS. THEY CONTINUALLY FAILED THE LEAK TEST. THE MANUFACTURER ATTEMPTED TO REPAIR THEM BUT WAS UNABLE TO FIND A SOLUTION. THEY ATTEMPTED SEVERAL DIFFERENT REPAIRS INCLUDING BUT NOT LIMITED TO REPLACING THE INTERNAL HOSE ASSEMBLY AND THE GAS OUTLET ON THE UNIT ITSELF. WE CONTINUED TO SEE THE SAME LEAK AND THE MANUFACTURER WAS UNABLE TO FIND A RESOLUTION. OUR CLINICAL ENGINEERING DIRECTOR DID SOME INDEPENDENT TESTING AND FOUND EXACTLY WHAT THE MEDICAL GAS CERTIFICATION COMPANY FOUND, A LEAK ON THE NITROUS OXIDE SYSTEM. SIX DIFFERENT SETS OF HOSES WERE TESTED AND FOUND IDENTICAL PROBLEMS. THEN ONE OF THE FACE PLATES ATTACHED TO THE HOSE ASSEMBLY WAS DISASSEMBLED, AND BRASS SHAVINGS WERE FOUND INSIDE THE OUTLET THAT WAS COMPROMISING THE INTEGRITY OF THE OUTLET. THE OUTLET WAS THEN CLEANED TO REMOVE THE SHAVINGS, AND THE O-RING WAS RE-LUBRICATED BEFORE REASSEMBLING. AFTER REASSEMBLING THE OUTLET, THE LEAK TEST WAS AGAIN PERFORMED AND IT PASSED. THE SAME PROCEDURE WAS THEN COMPLETED ON THE THREE OTHER HOSE ASSEMBLIES, ALL OF WHICH HAD BRASS SHAVINGS IN THEM, AND RECEIVED SIMILAR RESULTS. THE MANUFACTURER WE INFORMED OF THE ISSUE AND THEY STATED THEY WOULD LOOK INTO THE PROBLEM. ANOTHER ONE OF OUR HOSPITALS WAS ASKED TO CHECK THE OUTLETS ON THE UNITS THAT ARE CURRENTLY BEING INSTALLED IN THEIR OR. A TECH WENT UP AND REMOVED EACH OUTLET AND SHOOK THEM OVER A TABLE. THE NITROUS OUTLET HAD METAL SHAVINGS FALL OUT OF IT.THE MFR INFORMED US THAT THEY INSPECTED ALL OUTLETS CURRENTLY IN STOCK AT THEIR FACTORY IN CHINA AND FOUND SEVERAL WITH METAL SHAVINGS INTERNAL TO THEM.

    Description of Event or Problem · 1

    AFTER THE CEILING SUPPLY UNITS WERE INSTALLED IN A HYBRID OR, A MEDICAL GAS CERTIFICATION COMPANY ATTEMPTED TO CERTIFY THEM. THEY COULD NOT GET THE NITROUS OXIDE LINES ON BOTH UNITS TO PASS. THEY CONTINUALLY FAILED THE LEAK TEST. THE MANUFACTURER ATTEMPTED TO REPAIR THEM BUT WAS UNABLE TO FIND A SOLUTION. THEY ATTEMPTED SEVERAL DIFFERENT REPAIRS INCLUDING BUT NOT LIMITED TO REPLACING THE INTERNAL HOSE ASSEMBLY AND THE GAS OUTLET ON THE UNIT ITSELF. WE CONTINUED TO SEE THE SAME LEAK AND THE MANUFACTURER WAS UNABLE TO FIND A RESOLUTION. OUR CLINICAL ENGINEERING DIRECTOR DID SOME INDEPENDENT TESTING AND FOUND EXACTLY WHAT THE MEDICAL GAS CERTIFICATION COMPANY FOUND, A LEAK ON THE NITROUS OXIDE SYSTEM. SIX DIFFERENT SETS OF HOSES WERE TESTED AND FOUND IDENTICAL PROBLEMS. THEN ONE OF THE FACE PLATES ATTACHED TO THE HOSE ASSEMBLY WAS DISASSEMBLED, AND BRASS SHAVINGS WERE FOUND INSIDE THE OUTLET THAT WAS COMPROMISING THE INTEGRITY OF THE OUTLET. THE OUTLET WAS THEN CLEANED TO REMOVE THE SHAVINGS, AND THE O-RING WAS RE-LUBRICATED BEFORE REASSEMBLING. AFTER REASSEMBLING THE OUTLET, THE LEAK TEST WAS AGAIN PERFORMED AND IT PASSED. THE SAME PROCEDURE WAS THEN COMPLETED ON THE THREE OTHER HOSE ASSEMBLIES, ALL OF WHICH HAD BRASS SHAVINGS IN THEM, AND RECEIVED SIMILAR RESULTS. THE MANUFACTURER WE INFORMED OF THE ISSUE AND THEY STATED THEY WOULD LOOK INTO THE PROBLEM. ANOTHER ONE OF OUR HOSPITALS WAS ASKED TO CHECK THE OUTLETS ON THE UNITS THAT ARE CURRENTLY BEING INSTALLED IN THEIR OR. A TECH WENT UP AND REMOVED EACH OUTLET AND SHOOK THEM OVER A TABLE. THE NITROUS OUTLET HAD METAL SHAVINGS FALL OUT OF IT.THE MFR INFORMED US THAT THEY INSPECTED ALL OUTLETS CURRENTLY IN STOCK AT THEIR FACTORY IN (B)(6) AND FOUND SEVERAL WITH METAL SHAVINGS INTERNAL TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODUTEC CEILING MOUNT BYX MAQUET * *
    2 MODUTEC PLG CEILING MOUNT FSY MAQUET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *