BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM

    MDR report key: 1071667 · Received July 8, 2008

    Report

    Report Number
    2084725-2008-00354
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 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

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPLACED THE OIL MIST FILTER. THIS ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OIL MIST "HAZE" IN THE ROOM. THE CUSTOMER STATED ONE OF THE EMPLOYEES EXPERIENCED "CONGESTION OF MUCOUS IN THROAT AND LARYNX, LYMPH AREA SORE, CONSTANT ITCHING AND TINGLING SENSATION, BREATHING IN OF "POWDER-LIKE SUBSTANCE INTO LUNGS, ABLE TO TASTE CHEMICALS, SLEEPINESS, AND TIGHTNESS OF THE CHEST." THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR RECEIVE TREATMENT. 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 STERILIZER MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK