BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1203244 · Received October 17, 2008

    Report

    Report Number
    2084725-2008-00661
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 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
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OIL MIST. CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND THAT THERE WAS A HOLE IN THE OIL CAP ON THE VACUUM PUMP. THE FSE REMOVED AND REPLACED CAP. SYSTEM MEETS MANUFACTURER REQUIREMENTS. THE FSE RAN AN EMPTY CYCLE WITH NO ISSUES. RESULT: OIL CAP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAZE/ODOR COMING FROM THE STERRAD NX. THE CUSTOMER STATED THAT IT SMELLED LIKE OIL BURNING AND IT WAS GIVING OUT A CLOUDY HAZE. THERE WERE NO PHYSICAL COMPLAINTS RELATED TO THE HAZE/ODOR. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS 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