BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SINGLE-DOOR UNIT WITH STAINLESS STEEL EXTERIOR PANELS

    MDR report key: 1231051 · Received October 30, 2008

    Report

    Report Number
    2084725-2008-00714
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    YAMATO SCIENTIFIC CO.
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OIL MIST - CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE SAW AND SMELLED OIL MIST. THE FSE REPLACED THE OIL MIST FILTER ASSEMBLY. THE FSE TESTED FOR OIL MIST OR SMELL. THERE WAS NONE FOUND. THE FSE RAN EMPTY LOAD, ALL PASSED.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED THE OIL FILTER TO BE CHANGED. HE SAID IT SMELLED, BUT THERE WERE NO REPORTS OF WATERY EYES OR OTHER RELATED SYMPTOMS. 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 200 STERILIZATION SINGLE-DOOR UNIT WITH STAINLESS STEEL EXTERIOR PANELS STERILIZER, MEDICAL DEVICE MLR YAMATO SCIENTIFIC CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA