BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS

    MDR report key: 2100915 · Received May 19, 2011

    Report

    Report Number
    MW5020656
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STERIS COPORATION
    Product Code
    MED
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE ORDERED AND REC'D TWO NEW STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSORS, WHICH ARRIVED ON (B)(6) 2011. WE ARRANGED FOR A STERIS INSTALL TECHNICIAN TO DE-INSTALL TWO OLD SYSTEM 1 PROCESSORS AND INSTALL THE TWO NEW SYSTEM 1E PROCESSORS. ON APPROX (B)(6) 2011, THE FIRST NEW SYSTEM 1E PROCESSOR DID NOT FUNCTION PROPERLY WHEN INSTALLED. APPARENTLY, THERE IS AN ISSUE AT ELEVATION (WE ARE AT APPROX 7522 FT) THAT RESULTS IN THE AIR COMPRESSOR NOT BEING ABLE TO GENERATE ADEQUATE PSI. STERIS BROUGHT IN A SECOND COMPRESSOR, INSTALLED IT IN THE NEW SYSTEM 1E PROCESSOR AND IT LIKEWISE FAILED TO PRODUCE ADEQUATE PSI. WE HAD THEM DE-INSTALL THE NEW SYSTEM 1E AND THEIR ENGINEERS HAVE NOT YET BEEN ABLE TO RESOLVE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSOR MED STERIS COPORATION SYSTEM 1E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA