BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1082512 · Received July 24, 2008

    Report

    Report Number
    2084725-2008-00399
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-1631-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OIL MIST) - CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE FOUND OIL PLUG ON VACUUM PUMP HAD HOLE CAUSING MISTING ISSUE. THE FSE SENT THE CUSTOMER REPLACEMENT OIL PLUGS TO CORRECT PROBLEM. THIS ISSUE IS BEING ADDRESSED WITH A CUSTOMER LETTER, RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "OIL MIST HAZE". THE CUSTOMER STATED THAT THEY 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 NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA