BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM SINGLE-DOOR UNIT W/STAINLESS STEEL EXTERIOR

    MDR report key: 1060768 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00271
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OIL MIST - CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE CONFIRMED THE PROBLEM AND INSTALLED THE OIL MIST FILTER KIT. HE CERTIFIED THE SYSTEM WITH DIAGNOSTICS AND AN EMPTY CYCLE. THE SYSTEM MET SPECIFICATIONS. THIS ISSUE IS BEING ADDRESSED WITH A CUSTOMER LETTER, RELATED TO CORRECTION & REMOVAL #2084725.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OIL MIST. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS 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 W/STAINLESS STEEL EXTERIOR STERILIZER MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA