BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1053214 · Received May 28, 2008

    Report

    Report Number
    2084725-2008-00233
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-1630-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE CUSTOMER SITE. THE FSE REPLACED THE OIL MIST FILTER ELEMENT. THE FSE COMPLETED A SUCCESSFUL EMPTY CHAMBER CYCLE. THE UNIT MET PERFORMANCE SPECS. THIS ISSUE IS BEING ADDRESSED WITH A CUSTOMER LETTER, RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OIL MIST HAZE, THE NOTICED THE ISSUE RIGHT AWAY AND TURNED THE UNIT OFF. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL REACTIONS REPORTED. 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 200 STERILIZATION SYSTEM SINGLE-DOOR UNIT WITH STAINLESS STEEL EXTERIOR STERILIZER MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA