BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1231081 · Received October 30, 2008

    Report

    Report Number
    2084725-2008-00706
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT EVALUATED AT CUSTOMER SITE. THE FSE FOUND: UNIT WAS EMITTING ODOR DURING CYCLE. THE FSE NEVER SAW OIL MIST HAZE, HOWEVER, NOTICED ONLY THE SMELL. THE FSE REPLACED THE OIL MIST ASSEMBLY, CATALYTIC CONVERTER, VACUUM PUMP AND OIL RETURN VALVE. THE FSE PERFORMED VACUUM TEST, LEAKBACK, BARATRON ZERO AND RAN EMPTY CHAMBER CYCLE. NO OIL MIST HAZE/SMELL NOTICED. SYSTEM MEETS MANUFACTURES SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAZE/OIL MIST. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS. 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