BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1213697 · Received October 23, 2008

    Report

    Report Number
    2084725-2008-00684
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 23, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OIL MIST): CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPLACED THE OIL MIST FILTER, AND THE CATALYTIC CONVERTER BECAUSE THEY WERE MISTING. THE FSE VERIFIED THAT NO MIST WAS PRESENT. THE FSE VERIFIED THAT THE SYSTEM MEETS MANUFACTURERS SPECIFICATIONS. REFERENCE: MDR 2084725-2008-00683 AND MDR 2084725-2008-00685.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS PRODUCING AN OIL MIST/HAZE IN THE ROOM. THE CUSTOMER REPORTED THAT HE AND TWO OTHER EMPLOYEES EXPERIENCED SYMPTOMS. ONE OF THE TWO EMPLOYEES WHO WORKED ON NIGHT SHIFT REPORTED THAT SHE EXPERIENCED COUGHING AND RED AND WATERY EYES FOR ONE DAY. THE SYMPTOM OCCURRED WHEN THE SYSTEM WAS RUNNING. THE MIST WAS STILL IN THE AIR AFTER THE CYCLE. THE EMPLOYEE HAS NOT RESPONDED TO ASP'S ATTEMPTS IN RETRIEVING MORE INFORMATION ABOUT HER SYMPTOMS. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSES 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, CHEMICAL MLR YAMATO SCIENTIFIC CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR STERRAD CASSETTE