BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 50 STERILIZATION SYSTEM

    MDR report key: 1053215 · Received May 28, 2008

    Report

    Report Number
    2084725-2008-00234
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K981625
    Removal / Correction Number
    Z-1629-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE FOUND THE OIL MIST FILTER TO BE IN "GOOD SHAPE" BUT FOUND OIL BUILD UP AROUND THE ARM LEADING TO THE CATALYTIC CONVERTER. HE REPLACED THE OIL MIST FILTER AND ADJUSTED TENSION FOR THE OIL MIST FILTER HOUSING. HE RAN A FULLY CYCLE WHILE OBSERVING VACUUM SYSTEM FOR OIL MIST. THE UNIT WAS OPERATING WITH MFR SPECS. THIS ISSUE IS BEING ADDRESSED WITH A CUSTOMER LETTER, RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN "OIL MIST CLOUD" IN THEIR ROOM. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO REPAIR THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 50 STERILIZATION SYSTEM NONE MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA