BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARRAD NX STERILIZER

    MDR report key: 1191168 · Received September 26, 2008

    Report

    Report Number
    2084725-2008-00598
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT EVALUATED AT CUSTOMER SITE. THE FSE FOUND OIL MIST EMITTING FROM THE OIL FILTER CAP. CUSTOMER ALSO SAID THAT SYSTEM WAS NOISY WHEN VACUUM PUMP WAS FIRST TURNED ON. REPLACED VACUUM PUMP AND OIL RETURN TUBING. RAN VACUUM TESTING. REPLACED CRACKED DOOR HANDLE AS WELL. RAN AN EMPTY CHAMBER STANDARD CYCLE. SYSTEM PERFORMS TO SPECS. RESULT: OIL FILLER CAP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS FOG/APPEARANCE OF MIST IN THE ROOM WHEN THE UNIT IS RUNNING. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS RELATED TO THE MIST. THE ASP FIELD SVC ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA