BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1082510 · Received July 24, 2008

    Report

    Report Number
    2084725-2008-00400
    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
    K991999
    Removal / Correction Number
    Z-1628-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OIL MIST) - CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE FOUND THE UNIT MISTING AS REPORTED. THE FSE FOUND THE O-RING WAS OUT OF PLACE SO HE CORRECTED IT. HE RAN A DIAGNOSTIC EMPTY CHAMBER CYCLE, AND THE UNIT WAS OPERATING NORMALLY. THE UNIT MET MFR SPECIFICATIONS. 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 NOT EXPERIENCING ANY HUMAN REACTIONS. THE CUSTOMER TOOK THE UNIT OUT OF SERVICE. 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 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA